JSM 2017 Online Program

Legend:
CC = Baltimore Convention Center, H = Hilton Baltimore
* = applied session ! = JSM meeting theme

Activity Details

3 * !	Sun, 7/30/2017, 2:00 PM - 3:50 PM	CC-338
Statistical Methods for Health Economics and Applied Econometrics in Health Policy — Invited Papers
Health Policy Statistics Section , Business and Economic Statistics Section , Biopharmaceutical Section , Conference on Statistical Practice Steering Committee
Organizer(s): Sherri Rose, Harvard Medical School
Chair(s): Haochang Shou, University of Pennsylvania
2:05 PM	Computational Health Economics for Health Care Spending — Sherri Rose, Harvard Medical School ; Savannah Bergquist, Harvard University ; Tim Layton, Harvard Medical School
2:30 PM	Technical Solutions for Practical Problems in Accounting for Medical and Non-Medical Risk in Massachusetts' Medicaid Program — Arlene S. Ash, University of Massachusetts Medical School
2:55 PM	Statistical Methods for Developing Cost-Effective Biomarker Combinations for Disease Diagnosis and Prognosis — Aasthaa Bansal, University of Washington ; Patrick Heagerty, University of Washington ; Lotte Steuten, Fred Hutchinson Cancer Research Center
3:20 PM	Meta-Learners for Estimating Conditional Average Treatment Effects Using Machine Learning — Sören Künzel, UC Berkeley ; Jasjeet Sekhon, UC Berkeley ; Peter Bickel, UC Berkeley ; Bin Yu, University of California, Berkeley
3:45 PM	Floor Discussion

6 * !	Sun, 7/30/2017, 2:00 PM - 3:50 PM	CC-316
New Methods and Software for Adaptive Designs — Invited Papers
Biopharmaceutical Section , Biometrics Section , Section on Statistical Computing
Organizer(s): Jon Steingrimsson, Johns Hopkins University
Chair(s): Jon Steingrimsson, Johns Hopkins University
2:05 PM	Subgroup Inference for Multiple Treatments and Multiple Endpoints — Brad Carlin, University of Minnesota ; Patrick Schnell, University of Minnesota ; Peter Mueller, UT Austin ; Qi Tang, AbbVie, Inc.
2:25 PM	An Optimized Adaptive Enrichment Design for Multi-Arm Trials — Michael Rosenblum, Johns Hopkins University ; Aaron Fisher, Johns Hopkins University ; Jon Steingrimsson, Johns Hopkins University ; Joshua A Betz, Johns Hopkins University
2:45 PM	Bayesian Interval Based Dose Finding Designs and a Web-Based Statistical Tool — Yuan Ji, NorthShore University HealthSystem/University of Chicago ; Sue-Jane Wang, FDA ; Shengjie Yang, NorthShore University HealthSystem
3:05 PM	Open Source R, Shiny Interface and R Markdown: Applications for Group Sequential Design — Keaven Anderson, Merck Research Laboratories
3:25 PM	Discussant: Scott Emerson, University of Washington
3:45 PM	Floor Discussion

23 * !	Sun, 7/30/2017, 2:00 PM - 3:50 PM	CC-325
Increasing Efficiency and Integrity of Randomized Trials: Covariate-Adjusted Randomization and Monitoring Patient Accrual and Selection Bias — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Jonathan J Chipman, Vanderbilt University
Chair(s): William Rosenberger, George Mason University
2:05 PM	Techniques for Matched Randomization in Sequential Enrollment Trials — Jonathan J Chipman, Vanderbilt University ; Cole Beck, Vanderbilt University ; Robert A Greevy, Jr, Vanderbilt University
2:25 PM	Balanced Covariates with Response Adaptive Randomization — Benjamin Saville, Berry Consultants
2:45 PM	Sequential Patient Recruitment Monitoring — Dong-Yun Kim, NHLBI/NIH ; Sung-Min Han, OSEHRA
3:05 PM	Flexible Minimization: Synergistic Solution for Selection Bias — Donald Taves
3:25 PM	Floor Discussion

29 * !	Sun, 7/30/2017, 2:00 PM - 3:50 PM	CC-320
Bayesian Methods and Applications in Clinical Trials (I) — Contributed Papers
Biopharmaceutical Section
Chair(s): Jagadish Gogate, Johnson & Johnson
2:05 PM	Statistical Innovations on Safety Analyzes — Shuai Yuan, Merck ; William W Wang, Merck & Co Inc
2:20 PM	Statistical Monitoring of Safety via a Bayesian Predictive Approach — LiAn Lin ; Greg Ball, Merck ; William W Wang, Merck & Co Inc
2:35 PM	Bayesian Methods for Analysis of Biosimilar Phase III Trials — Robert Weiss, UCLA Fielding School of Public Health ; Xiaomao Simon Xia, University of Missouri ; Nan Zhang, Amgen Inc ; Hui Wang, Amgen Inc ; Eric Chi, Amgen, Inc.
2:50 PM	Comparing ITT Estimates with Adherence Adjusted Estimates Based on the Rubin Causal Model — Sreelatha Meleth, RTI International ; Barry Eggleston, RTI International
3:05 PM	Borrowing Historical Information for Clinical Development - a Case Study — Guochen Song, Biogen ; Peng Sun, Biogen ; John Zhong, Biogen ; Jie Li, Biogen ; Baoguang Han, Biogen ; Stacy Lindborg, Biogen
3:20 PM	Expanding the Role of N-Of-1 Trials in Regulated Clinical Trials — Samuel Dickson, USAMMDA Biostatistics Branch ; Sharon A Gilbert, USAMMDA Biostatistics Branch ; Cynthia V. Landefeld, USAMMDA Biostatistics Branch ; Nan Guo, USAMMDA Biostatistics Branch ; William F. McCarthy, USAMMDA Biostatistics Branch
3:35 PM	Floor Discussion

60 * !	Sun, 7/30/2017, 4:00 PM - 5:50 PM	CC-316
Adaptive Design and Statistical Consideration in Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section , Section on Statistical Computing , Section on Medical Devices and Diagnostics
Organizer(s): Grace Liu, Johnson & Johnson
Chair(s): Grace Liu, Johnson & Johnson
4:05 PM	Investigation on Combining Phase II Proof-Of-Concept Trial with Dose Finding Trial — Yutao Liu, Columbia University ; Qiqi Deng, Boehringer Ingelheim Pharmaceuticals, Inc. ; Ken Cheung, Deptment of Biostatistics, Columbia University
4:25 PM	Adaptive Design and Statistical Consideration in Clinical Trials — Steven Sun ; Grace Liu, Johnson & Johnson ; Tianmeng Lyu, Univ. Minnesota Biostatistics Dept.
4:45 PM	Basket Trial Considerations in Phase Ib/IIa Oncology Studies of Targeted Therapy — Yihua Zhao, Boehringer Ingelheim Pharmaceuticals, Inc.
5:05 PM	Evaluation of Adaptive Sample Size Re-estimation (SSR) Designs:start small then ask for more? — Chaofeng Liu
5:25 PM	Design of Dose Finding Studies Under MCP-Mod — Jose Pinheiro, Johnson & Johnson
	Discussant: Sudhakar Rao
5:45 PM	Floor Discussion

63 * !	Sun, 7/30/2017, 4:00 PM - 5:50 PM	CC-323
Statistical Methods for Brain Connectivity and Network Analysis — Topic Contributed Papers
Section on Bayesian Statistical Science , Biopharmaceutical Section , Section on Statistics in Imaging
Organizer(s): Phebe B Kemmer, Eli Lilly and Company
Chair(s): Ixavier Higgins, Emory University
4:05 PM	A Longitudinal Model for Functional Connectivity Using fMRI — Brian Hart, University of Minnesota-Div of Biostatistics ; Ivor Cribben, University of Alberta ; Mark Fiecas, University of Minnesota
4:25 PM	Estimating Dynamic Brain Functional Networks Using Multi-Subject fMRI Data — Suprateek Kundu, Emory University, Rollins School of Public Health
4:45 PM	Clustering DTI Data to Identify White Matter Fiber Bundles Using a Mixture of Langevin Distribution — Subhadip Pal, University of Louisville
5:05 PM	Towards Identifying and Refining Individual Connectivity Patterns in the Human Brain — Joaquin Goni, Purdue University ; Enrico Amico, Purdue University
5:25 PM	Use of Brain Connectivity Information in Regression Parameter Estimation via Generalized Regularization — Damian Brzyski, Indiana University ; Marta Karas, Indiana University ; Joaquin Goni, Purdue University ; Beau Ances, Washington University School of Medicine ; Timothy Randolph, Fred Hutchinson Cancer Research Center ; Jaroslaw Harezlak, Indiana University School of Public Health
5:45 PM	Floor Discussion

66 * !	Sun, 7/30/2017, 4:00 PM - 5:50 PM	CC-321
ICH E17 and Multi-Regional Clinical Trials (MRCTs) — Topic Contributed Panel
Biopharmaceutical Section
Organizer(s): Shuai Yuan, Merck
Chair(s): William W Wang, Merck & Co Inc
4:05 PM	Multi-Regional Clinical Trials and the ICH E17 Draft Guidance
Panelists:	Bruce Binkowitz, Shionogi, Inc. Aloka Chakravarty, US FDA, CDER Steve Snapinn, Amgen Romi Singh, Pfizer
5:40 PM	Floor Discussion

83	Sun, 7/30/2017, 8:30 PM - 10:30 PM	CC-Halls A&B
Your Invited Poster Evening Entertainment: No Longer Board — Invited Poster Presentations
Astrostatistics Special Interest Group , Biometrics Section , Biopharmaceutical Section , Business and Economic Statistics Section , ENAR , Government Statistics Section , IMS , International Society for Bayesian Analysis (ISBA) , Section for Statistical Programmers and Analysts , Section on Statistical Consulting , Section on Statistical Education , Section on Statistical Learning and Data Science , Section on Statistics and the Environment , Social Statistics Section , Survey Research Methods Section , Section on Statistics in Genomics and Genetics
Chair(s): Jessi Cisewski, Yale University
1:	Overview of SAMSI Program on Statistical, Mathematical and Computational Methods for Astronomy (ASTRO) — Gutti Jogesh Babu, The Pennsylvania State University ; David Jones, SAMSI / Duke
2:	A Multi-Resolution 3D Map of the Intergalactic Medium via the Lyman-Alpha Forest — Collin Eubanks, Carnegie Mellon University ; Jessi Cisewski, Yale University ; Rupert Croft, Carnegie Mellon University ; Doug Nychka, National Center for Atmospheric Research ; Larry Wasserman, Carnegie Mellon
3:	Testing Bayesian Galactic Mass Estimates Using Outputs from Hydrodynamical Simulations — Gwendolyn Eadie, McMaster University ; Benjamin Keller, McMaster University ; William Harris, McMaster University ; Aaron Springford, Queen's University
4:	Quantifying Discovery in Astro/Particle Physics: Frequentist and Bayesian Perspectives — David Van Dyk, Imperial College London ; Sara Algeri, Imperial College London ; Jan Conrad, University of Stockholm
5:	Computer Model Calibration to Enable Disaggregation of Large Parameter Spaces, with Application to Mars Rover Data — David Craig Stenning, SAMSI/Duke University ; Working Group 1 ASTRO Program, SAMSI
6:	The Association Between Copy Number Aberration, DNA Methylation, and Gene Expression — Wei Sun, Fred Hutchinson Cancer Research Center
7:	Rerandomization: a Flexible Framework for Experimental Design — Kari Lock Morgan, Penn State University
8:	IMs for IVs: An Inferential Model Approach to Instrumental Variable Regression — Nicholas Aaron Syring, NCSU ; Ryan Martin, NCSU
9:	Detecting Differential Gene Expression by Single-Cell RNA Sequencing — Mingyao R Li, University of Pennsylvania ; Cheng Jia, University of Pennsylvania ; Nancy Ruonan Zhang, Wharton School , University of Pennsylvania
10:	Statistical Science and Policy at the EPA — Elizabeth Mannshardt, US Environmental Protection Agency
11:	Approximate Message Passing Algorithms for High-Dimensional Regression — Cynthia Rush, Columbia University
12:	Generalized Fiducial Inference for High-Dimensional Data — Jan Hannig, University of North Carolina at Chapel Hill ; Jonathan P Williams, University of North Carolina at Chapel Hill
13:	The Combination of Confirmatory and Contradictory Statistical Evidence at Low Resolution — Ruobin Gong, Harvard University ; Xiao-Li Meng, Harvard University
14:	Approximate Confidence Distribution Computing: An Effective Likelihood-Free Method with Statistical Guarantees — Suzanne Thornton, Rutgers University ; Minge Xie, Rutgers University
15:	R Package TDA for Statistical Inference on Topological Data Analysis — Jisu Kim, Carnegie Mellon University
16:	Teaching a Large, Project-Based Statistical Consulting Class — Emily Griffith, NC State University
17:	Transforming Undergraduate Statistics Education Through Experiential Learning: It's Essential! — Tracy Morris, University of Central Oklahoma ; Cynthia Murray, University of Central Oklahoma ; Tyler Cook, University of Central Oklahoma
18:	The Geometry of Synchronization Problems and Learning Group Actions — Tingran Gao, Duke University ; Jacek Brodzki, University of Southampton ; Sayan Mukherjee, Duke University
19:	Sufficient Markov Decision Processes with Alternating Deep Neural Networks — Longshaokan Wang, North Carolina State University ; Eric Laber, North Carolina State University ; Katie Witkiewitz, University of New Mexico
20:	Optimal Dynamic Treatment Regimes Using Decision Lists — Yichi Zhang, Harvard University ; Eric Laber, North Carolina State University ; Anastasios (Butch) Tsiatis, North Carolina State University ; Marie Davidian, North Carolina State University
21:	Predicting Phenotypes from Microarrays Using Amplified, Initially Marginal, Eigenvector Regression — Lei Ding, Indiana University ; Daniel J. McDonald, Indiana University
22:	Computer Vision Meets Television — Taylor Arnold, University of Richmond ; Lauren Tilton, University of Richmond
23:	Generalized Fiducial Inference for Nonparametric Function Estimation — Randy C.S. Lai, University of Maine
24:	A Phylogenetic Transform Enhances Analysis of Compositional Microbiota Data — Justin David Silverman, Duke University ; Sayan Mukherjee, Duke University ; Lawrence A David, Duke University
25:	Bayesian Multispecies Ecological Models for Paleoclimate Reconstruction Using Inverse Prediction — John Tipton, Colorado State University ; Mevin Hooten, Colorado State University
26:	Fast Maximum Likelihood Inference for Spatial Generalized Linear Mixed Models — Yawen Guan, Penn State University ; Murali Haran, Pennsylvania State University
27:	Fair Prediction with Disparate Impact: a Study of Bias in Recidivism Prediction Instruments — Alexandra Chouldechova, Carnegie Mellon University
28:	I Ran a Nonresponse Follow-Up Survey; Now What Do I Do? — Phillip Kott, RTI

214676	Mon, 7/31/2017, 7:30 AM - 12:30 PM	H-Ruth
Biopharmaceutical Section Executive Committee Meeting (Closed) — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Alex Dmitrienko, Mediana Inc

CE_14C	Mon, 7/31/2017, 8:00 AM - 12:00 PM	H-Key Ballroom 8
Multi-Regional Clinical Trials and the ICH E17 (ADDED FEE) — Professional Development Continuing Education Course
ASA , Biopharmaceutical Section
Instructor(s): William Wang, Merck, Aloka Chakravarty, US FDA, CDER, Lisa LaVange, US FDA, CDER, Bruce Binkowitz, Shionogi, Inc.
8:00 AM	Multi-Regional Clinical Trials and the ICH E17 (ADDED FEE) — William Wang, Merck ; Aloka Chakravarty, US FDA, CDER ; Lisa LaVange, US FDA, CDER ; Bruce Binkowitz, Shionogi, Inc.

95 * !	Mon, 7/31/2017, 8:30 AM - 10:20 AM	CC-303
Statistical Validation of Surrogate Endpoints — Invited Papers
Pharmaceutical Research and Manufacturers of America , Biopharmaceutical Section , ENAR
Organizer(s): Hong Tian, Janssen Research and Development
Chair(s): Sudhakar Rao
8:35 AM	Response Biomarker Versus Surrogate Endpoints Validation: Evolution of Statistical Approaches — Sue-Jane Wang, FDA
9:00 AM	Surrogacy for Regulatory Approval: The Follicular Lymphoma Analysis of Surrogate Hypothesis (FLASH) Project — Qian Shi, Mayo Clinic
9:25 AM	The Surrogate Threshold Effect for Event-Free Survival as a Potential Surrogate for Overall Survival in Patients Treated for Acute Myeloid Leukemia — Marc Buyse, IDDI Inc. ; Richard Schlenk, University Hospital of Ulm, Germany ; Hartmund Dohner, University Hospital of Ulm, Germany ; Tomasz Burzykowski, IDDI S.A.
9:50 AM	Issues Related to Statistical Validation of Minimal Residual Disease as a Surrogate Endpoint for Clinical Trials and Drug Approvals in AML — Liang Xiu, Janssen Research and Development ; Rianka Bhattacharya, Janssen Research and Development ; Jianan Hui, University of California, Riverside ; Hong Tian, Janssen Research and Development
10:15 AM	Floor Discussion

113 * !	Mon, 7/31/2017, 8:30 AM - 10:20 AM	CC-317
Clinical Outcome Assessments: Measurement, Evaluation, and Interpretation — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Xu Shu, Novartis
Chair(s): Dong Xi, Novartis Pharmaceuticals Corporation
8:35 AM	Generalizability Theory for Clinician-Rated Outcomes — Joseph Cappelleri, Pfizer Inc
8:55 AM	Exploring the Cognitive Endpoints in Alzheimer's Disease Cohort Data Using Item Response Theory Models — Xu Shu, Novartis
9:15 AM	Estimating Real Cigarette Counts from Heaped Time-Line Follow-Back Data — Chelsea McCarty Allen, Southern Methodist University ; Daniel F. Heitjan, Southern Methodist University
9:35 AM	Patient-Reported Outcomes: Observations of Regulatory Approvals by the Center for Biologics Evaluation and Research — Hussein Ezzeldin, FDA/CBER ; Megan Moncur, FDA/CBER ; Yuqun Abigail Luo, FDA/CBER ; Telba Irony, Office of Biostatistics and Epidemiology, CBER, FDA
9:55 AM	Mixed Methods for Analyzing Factors Important to Patients in Choosing a Dialysis Modality — Jarcy Zee, Arbor Research Collaborative for Health ; Lalita Subramanian, Arbor Research Collaborative for Health ; Junhui Zhao, Arbor Research Collaborative for Health ; Francesca Tentori, Arbor Research Collaborative for Health; Vanderbilt University
10:15 AM	Floor Discussion

123 * !	Mon, 7/31/2017, 8:30 AM - 10:20 AM	CC-309
Topics for the Statistician Clinical Trialist — Contributed Papers
Biopharmaceutical Section
Chair(s): Laurence Colin, Novartis
8:35 AM	Improving Power in Group Sequential, Randomized Trials by Adjusting for Prognostic Baseline Variables and Short-Term Outcomes — Tianchen Qian, Johns Hopkins University ; Michael Rosenblum, Johns Hopkins University ; Huitong Qiu, Vatic Lab
8:50 AM	Predicted Clinical Outcomes Using an Adaptive Markov Random Jump Model Within a Recursive Process: A Case Study — D. Purkayastha
9:05 AM	A Method for Visualizing Continuous Glucose Patterns Using B-Splines and T-Distributed Stochastic Neighbor Embedding — Hui Zheng, Harvard Medical School
9:20 AM	Evaluation of Hazard Ratio Estimators of Survival Data — Gang Li, Johnson & Johnson ; Yining Wang, Johnson & Johnson ; Weichung Joe Shih, Rutgers School of Public Health
9:35 AM	Regional Efficacy Assessment in Multi-Regional Clinical Development — Lanju Zhang, AbbVie, Inc. ; yijie zhou, Abbvie ; lu cui, Abbvie ; bo yang, Vertex ; frank shen, Abbvie
9:50 AM	Analytical Framework for Safety Assessment Committee (SAC) in Drug Development — Amit Bhattacharyya, ACI Clinical ; Jonathan Seltzer, ACI Clinical
10:05 AM	Floor Discussion

124 * !	Mon, 7/31/2017, 8:30 AM - 10:20 AM	CC-319
Special Topics in Clinical Trial Design and Analysis — Contributed Papers
Biopharmaceutical Section
Chair(s): Isaac Nuamah, Janssen R & D
8:35 AM	Selection Bias in Studies with Unequal Allocation — Olga M Kuznetsova, Merck & Co., Inc.
8:50 AM	Phase II Trials and the Use of Registry Controls — Ruta Brazauskas, Institute for Health & Society-Medical College of Wisconsin ; Brent Logan, Institute for Health & Society-Medical College of Wisconsin ; Raphael Fraser, Institute for Health & Society-Medical College of Wisconsin
9:05 AM	Simulation-Based Evaluation of P-Value Quality in Phase 3 Clinical Trials — Jihao Zhou, Allergan, Inc. ; Ray Zhu, Allergan, Inc. ; Brandon Wales, University of California at Riverside ; Thomas Lin, University of California at Irvine
9:20 AM	Inverse Probability of Treatment Weighted Estimator for Exposure Adjusted Incidence Rate Ratio for Rare Adverse Event in Pooled Studies Controlling for Confounding by Study — Hui Wang, Astrazeneca ; Sudipta Bhattacharya, AstraZeneca
9:35 AM	Flexible Hypothesis Testing Method for Clinical Trials Using Composite Endpoint — Jin Xu, Merck ; David Li, Pfizer
9:50 AM	Optimal Design of Experiments with the Observation Censoring Driven by Random Enrollment of Subjects — Xiaoqiang Xue ; Valerii Fedorov, ICONplc
10:05 AM	Floor Discussion

CE_15C	Mon, 7/31/2017, 8:30 AM - 5:00 PM	H-Key Ballroom 11
Statistical Analysis of Medical Product Safety Data and Benefit-Risk Assessment (ADDED FEE) — Professional Development Continuing Education Course
ASA , Biopharmaceutical Section
Instructor(s): Jie Chen, Novartis Pharmaceutical Corporation, Joseph Heyse, Merck & Co., Inc., Tze Leung Lai, Stanford University
8:30 AM	Statistical Analysis of Medical Product Safety Data and Benefit-Risk Assessment (ADDED FEE) — Jie Chen, Novartis Pharmaceutical Corporation ; Joseph Heyse, Merck & Co., Inc. ; Tze Leung Lai, Stanford University

140 * !	Mon, 7/31/2017, 10:30 AM - 12:20 PM	CC-314
The Challenges and Advantages of Utilizing Bayesian Statistical Methodology in Extrapolation of Adult Use Data to Pediatric Study Designs and Evaluation — Invited Papers
Biopharmaceutical Section , Section on Bayesian Statistical Science , Biometrics Section
Organizer(s): Yodit Seifu, Ferring Pharmaceuticals
Chair(s): Yodit Seifu, Ferring Pharmaceuticals
10:35 AM	Bayesian Statistics in Extrapolation for Pediatric Trials — Freda Cooner, FDA/CDER/OTS/OB
10:55 AM	Bayesian Statistical Methodologies for Evaluating Similarity in Exposure-Response Relationship Between Adults and Pediatrics — Mathangi Gopalakrishnan, Center for Translational Medicine, University of Maryland, Baltimore
11:15 AM	Bayesian and Frequentist Partial Extrapolation Approaches in Organ Transplantation to Support the Pediatric Plan for European Health Authorities — Steffen Ballerstedt, Novartis Pharma AG ; Jennifer Ng, Novartis Pharmaceuticals Inc
11:35 AM	Using Bayesian Methods to Incorporate Historical Information on Control Rate and Treatment Effect: An HIV-Paediatric Trial — Clara Dominguez Islas, MRC Biostatistics Unit ; Nicky Best, GlaxoSmithKline ; Rebecca Turner, MRC Biostatistics Unit ; Naomi Givens, GlaxoSmithKline ; Rimgaile Urbaityte, GlaxoSmithKline ; Sophie Barthel, GlaxoSmithKline ; Adrian Mander, MRC Biostatistics Unit
11:55 AM	Discussant: Margaret Gamalo-Siebers, Eli Lilly
12:15 PM	Floor Discussion

151 *	Mon, 7/31/2017, 10:30 AM - 12:20 PM	CC-317
Enrichment Clinical Trials: Novel Designs, Statistical Inferences, and Case Studies — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Yili L Pritchett, MedImmune
Chair(s): Zhenzhen Xu, FDA/CBER
10:35 AM	Enrichment by Response: Sequential Parallel Comparison Design — Anastasia Ivanova, UNC at Chapel Hill
10:55 AM	Estimators and Confidence Intervals for Adaptive Two-Stage Designs for Population Enrichment — Vladimir Dragalin, Janssen R&D ; Ionut Bebu, The George Washington University
11:15 AM	An Adaptive Subgroup-Identification Enrichment Design — Yanxun Xu, Johns Hopkins University ; Yili L Pritchett, MedImmune ; Florica Constantine, Johns Hopkins University
11:35 AM	Assessment of Utility of Total Kidney Volume for Trial Enrichment — John Lawrence
11:55 AM	Discussant: Yili L Pritchett, MedImmune
12:15 PM	Floor Discussion

187	Mon, 7/31/2017, 12:30 PM - 1:50 PM	CC-Ballroom II
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Qi Jiang, Amgen Inc.
ML09:	Applying Bayesian Methodology to Precision Medicine — Judy X. Li, Regeneron Pharmaceuticals
ML10:	FDA Draft Guidance on Multiple Endpoints — Kate Liu, Amgen, Inc.
ML11:	How to Treat Site in Clinical Trials - Fixed or Random? — Chul Ahn, FDA
ML12:	How We Take Advantage of Big Data When Dealing with the Dilemma in Early-Phase Oncology? — Shaoyi Li, Celgene
ML13:	Non-Inferiority Trials for Efficacy and Safety — Steve Snapinn, Amgen

218 * !	Mon, 7/31/2017, 2:00 PM - 3:50 PM	CC-316
Efficient Designs and Better Decision-Making Strategies in Complex Clinical Trials: Multiple Arms, Multiple Endpoints, and Multiple Stages — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Scott Evans, Harvard University
Chair(s): Scott Evans, Harvard University
2:05 PM	A Simple and Flexible Graphical Approach for Adaptive Group-Sequential Clinical Trials — Frank Bretz, Novartis AG ; Toshifumi Sugitani, Astellas ; Willi Maurer, Novartis
2:25 PM	Adaptive Multi-Arm Multi-Stage Designs — Cyrus Mehta, Cytel Inc ; Pranab Ghosh, Cytel Inc, Boston University
2:45 PM	Designing Multi-Stage Clinical Trials with Multiple Event-Time Endpoints — Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center ; Scott Evans, Harvard University ; Tomoyuki Sugimoto, Kagoshima University ; Koko Asakura, National Cerebral and Cardiovascular Center
3:05 PM	Confirmatory Group Sequential Adaptive Designs for Time-To-Event Endpoints Using a Short-Term Endpoint for Treatment Arm or Population Selection — Gernot Wassmer, Medical University of Vienna, Austria ; Martin Posch, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University o ; Franz Koenig, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University o ; Silke Joergens, ICON Clinical Research Inc, Cologne Germany
3:25 PM	Discussant: Hsien-Ming James Hung, U.S. Food and Drug Administration
3:45 PM	Floor Discussion

223 * !	Mon, 7/31/2017, 2:00 PM - 3:50 PM	CC-315
Clinical Trials: Recent Statistical Advances for Enabling Personalized Medicine — Topic Contributed Papers
Biopharmaceutical Section , Section on Statistics in Genomics and Genetics , Section on Medical Devices and Diagnostics
Organizer(s): Devan Mehrotra, Merck & Co. Inc.
Chair(s): Donna L Kowalski, Astellas Pharma, US
2:05 PM	Methods of Biomarker and Subgroup Identification for Personalized Medicine — Ilya Lipkovich, QuintilesIMS ; Bohdana Ratitch , QuintilesIMS ; Alex Dmitrienko, Mediana Inc
2:25 PM	Measuring Differential Treatment Benefit Across Marker Specific Subgroups: The Choice of Outcome Scale — Alexia Iasonos, Memorial Sloan Kettering Sloan Cancer Center ; Jaya Satagopan, Memorial Sloan Kettering Cancer Center
2:45 PM	A Powerful Learn-And-Confirm Pharmacogenomics Methodology for Randomized Clinical Trials — Devan Mehrotra, Merck & Co. Inc. ; Qian Guan, North Carolina State University ; Zifang Guo, Merck & Co., Inc.
3:05 PM	Efficient Approaches to Identifying Markers That Predict Treatment Effects in Randomized Clinical Trials — James Dai, Fred Hutchinson Cancer Research Center ; Michael LeBlanc, Fred Hutchinson Cancer Research Center
3:25 PM	Clinical Trial Designs of Predictive Markers — Meijuan Li, CDRH/FDA
3:45 PM	Floor Discussion

231	Mon, 7/31/2017, 2:00 PM - 3:50 PM	CC-312
Biopharmaceutical Section Student Papers — Contributed Papers
Biopharmaceutical Section
Chair(s): Hiya Banerjee, Novartis
2:05 PM	A Latent Variable Approach to Elicit Continuous Toxicity Scores and Severity Weights for Multiple Toxicities in Dose-Finding Oncology Trials — Nathaniel O'Connell, Medical University of South Carolina ; Elizabeth Garrett-Mayer, Medical University of South Carolina
2:20 PM	D-Learning to Estimate Optimal Individual Treatment Rules — Zhengling Qi, University of North Carolina, Chapel Hill ; Yufeng Liu, University of North Carolina
2:35 PM	Joint Analysis of Left-Censored Longitudinal Biomarker and Binary Outcome via Latent Class Modeling — Menghan Li, Pennsylvania State University ; Lan Kong, Pennsylvania State University
2:50 PM	ASID: A Bayesian Adaptive Subgroup-Identification Enrichment Design — Florica Constantine, Johns Hopkins University ; Yanxun Xu, Johns Hopkins University ; Yili L Pritchett, MedImmune ; Zhilin Jin, Johns Hopkins University
3:05 PM	Meta-Analysis of Rare Binary Events in Treatment Groups with Unequal Variability — Lie Li ; Xinlei Wang, Southern Methodist University
3:20 PM	Floor Discussion

243	Mon, 7/31/2017, 2:00 PM - 3:50 PM	CC-Halls A&B
Contributed Poster Presentations: Biopharmaceutical Section — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Jessi Cisewski, Yale University
17:	Event Rate Estimation Based on Blinded Time-To-Event Data to Verify Sample Size Calculation Assumptions — Youlan Rao, United Therapeutics Corporation, Durham, NC ; Suhyun Kang, North Carolina State University, Raleigh, NC ; Jody Cleveland, United Therapeutics Corporation, Durham, NC ; Chunqin Deng, United Therapeutics Corporation, Durham, NC
18:	Generalized Youden's Index to Derive the Optimal Thresholds for Discriminant Analysis — Kelly H. Zou, Pfizer Inc ; Ching-Ray Yu, Pfizer Inc ; Jason Pan, Pfizer Inc ; Dhaval Patel, Pfizer Inc ; Martin Carlsson, Pfizer Inc
19:	Sample Size Calculation in Clinical Trials with Binary Co-Primary Endpoints or Multiple Testing Procedures — Zuoshun Zhang, Celgene Corporation
20:	Survival Prediction in Early-Stage Lung Cancer via Bayesian Model Averaging of Nonparametric Accelerated Failure Time Models — Kijoeng Nam, Merck ; Nicholas Henderson, Johns Hopkins University ; Dai Feng, Merck
21:	An Evaluation of Multiple Imputation Methods for Hierarchical Data — Takayuki Abe, Keio University School of Medicine ; Manabu Iwasaki, Seikei University
22:	A Bayesian Adaptive Design in Cancer Phase I Trials Using Dose Combinations with Ordinal Toxicity Grades — Sungjin Kim, Cedars-Sinai Medical Center ; Marcio Diniz, Cedars Sinai Medical Center ; Mourad Tighiouart, Cedars-Sinai Medical Center
23:	Constrained Longitudinal Model for Analyzing Pre- and Post-Treatment Count Data — Yongming Qu, Eli Lilly and Company ; Junxiang Luo, Eli Lilly and Company ; Hong Zhao, Abbott Laboratories
24:	A Curtailed Design for Selecting the t Best Among Bernoulli Treatments and a Control — Mingyue Wang, Syracuse University ; Pinyuen Chen, Syracuse University
25:	Two-Stage Design for Phase II Cancer Clinical Trials with Multiple Endpoints — Hui Gu, Rutgers University ; Yong Lin, Rutgers ; Weichung Joe Shih, Rutgers School of Public Health ; Yaqun Wang, Rutgers ; Kejian Liu, Celgene
26:	Drug Combination Dose Allocation Using Minimal Sets and Coherence in Partially Ordered Sets in Phase I Cancer Trials — Galen Cook-Wiens, Cedars Sinai Medical Center ; Matthieu Clertant, Cedars-Sinai Medical Center ; Mourad Tighiouart, Cedars-Sinai Medical Center
27:	Interim Analysis with Short-Term and Long-Term Endpoint in Adaptive Group Sequential Design — Lin Pan, ICON PLC ; Jill Stankowski, ICON PLC
28:	Sample Size Calculation Based on Finite Mixture Model — Zejiang Yang, INC Research
29:	Local Odds Ratio Is More Efficient Than Correlation Coefficient For Modeling Longitudinal Ordinal Data — Xinkai Zhou, Statistics Core@UCLA ; Ronghui Xu, University of California, San Diego ; David Elashoff, University of California, Los Angeles
30:	Modeling Excess Zeroes in an Integrated Analysis of Vaccine Safety — Roger Maansson, Pfizer Inc. ; David Radley, Pfizer Inc. ; Qin Jiang, Pfizer Inc. ; Scott Patterson, Pfizer Inc. ; Judith Absalon, Pfizer Inc. ; John Perez, Pfizer Inc.
31:	Using an Onset-Anchored Bayesian Hierarchical Model to Improve Predictions for Amyotrophic Lateral Sclerosis Disease Progression — Alex Karanevich
32:	What Is the Best Design for Dose-Finding Trials with Small Number of Doses? — Lai Wei ; Julie Stephens, The Ohio State Univeristy ; Vedat Yildiz, The Ohio State University ; Marilly Palettas, The Ohio State University ; Songzhu Zhao, The Ohio State University ; Xueliang Pan, The Ohio State Univeristy
33:	An R Shiny Foundation for Standardized Clinical Review Tools — Jimmy Wong, FDA
34:	Analysis Timing in Oncology Immunotherapy Trials with a Late Separation of Overall Survival Curve — Shu-Chih Su, Merck
35:	Analysis of Adverse Event Relationships in Clinical Trials Using JMP — Anastasia Dmitrienko ; Kelci Miclaus, JMP Life Sciences, SAS Institute Inc. ; Richard C. Zink, JMP Life Sciences, SAS Institute, Inc.
37:	Sample Size Re-Estimation and Other Midcourse Adjustments with Sequential Parallel Comparison Design — Rachel Silverman, University of North Carolina ; Anastasia Ivanova, UNC at Chapel Hill
38:	A Modified LOCF-PMM Method with Multiple Imputation for Handling Missing Data in Longitudinal Studies — Busola Sanusi, The University of North Carolina at Chapel Hill ; Kenneth Liu, Merck & Co. ; Gregory Golm, Merck & Co., Inc.
40:	A Simulation Study to Evaluate the Performance of Different Exposure Response Analyzes Using Concentration-QTc Data — Dalong Huang, FDA
41:	Sensitivity Analysis of Andersen-Gill Model — Dongmei Lan ; Jill Stankowski, ICON PLC
42:	Design of Drug Combination Early Phase Cancer Trials Using Time to Toxicity Data — Marcio Diniz, Cedars Sinai Medical Center ; José Jimenez, Politecnico di Torino ; Andre Rogatko, Cedars Sinai Medical Center ; Mourad Tiguiouart, Cedars Sinai Medical Center
43:	Emax Modeling for Assessing Dose-Response Relationships Using JMP — Beibo Zhao, University of North Carolina at Chapel Hill ; Richard C. Zink, JMP Life Sciences, SAS Institute, Inc.
46:	Quantitative Analysis of Spreading Defects and Response to Therapeutics in Lowe Syndrome — Brittany Griggs, Purdue University ; Swetha Ramadesikan, Purdue University ; Ruben Claudio Aguilar, Purdue University
48:	Comparing Two Correlated ROC Curves: a Generalized Pivotal Quantity Approach — Yonggang Zhao, Skyview Research ; Qianqiu Li, Johnson and Johnson
49:	dECiDe: software developed by Cytel and AstraZeneca for early clinical study design — Patrick D. Mitchell, Early Clinical Development AstraZeneca ; Dominic Magirr, AZ IMED Biotech Unit, ECD Biometrics ; Elizabeth Pilling, AZ IMED Biotech Unit, ECD Biometrics ; James Matcham, AZ IMED Biotech Unit, ECD Biometrics ; Jaydeep Bhattacharyya, Cytel Inc. ; Charles Liu, Cytel Inc.

256	Tue, 8/1/2017, 7:00 AM - 8:15 AM	CC-Ballroom II
CANCELLED: Biopharmaceutical Section A.M. Roundtable Discussion (Added Fee) — Roundtables AM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Qi Jiang, Amgen Inc.

277 *	Tue, 8/1/2017, 8:30 AM - 10:20 AM	CC-328
Advances in Joint Modeling and Predicting Heterogeneous Outcomes — Invited Papers
ENAR , Biometrics Section , Biopharmaceutical Section
Organizer(s): Abdus Sattar, Case Western Reserve University
Chair(s): Jeffrey Albert, Case Western Reserve University
8:35 AM	Joint Nonparametric Correction Estimator for Excess Relative Risk Regression in Survival Analysis with Exposure Measurement Error — Ching-Yun Wang, Fred Hutchinson Cancer Research Center ; Harry Cullings, Radiation Effects Research Foundation ; Xiao Song, University of Georgia ; Kenneth J. Kopecky, Fred Hutchinson Cancer Research Center
9:00 AM	Bayesian Clinical Trial Design for Joint Models of Longitudinal and Survival Data — Joseph G Ibrahim, UNC ; Matthew Psioda, UNC Chapel Hill
9:25 AM	Joint Modeling of Longitudinal and Survival Data with a Covariate Subject to a Limit of Detection — Abdus Sattar, Case Western Reserve University ; Sanjoy K Sinha, Carleton University
9:50 AM	Discussant: Dimitris Rizopoulos, Erasmus University Medical Center
10:15 AM	Floor Discussion

278	Tue, 8/1/2017, 8:30 AM - 10:20 AM	CC-327
Statistical Programmers: New Brand of Leaders — Invited Panel
Section for Statistical Programmers and Analysts , Biopharmaceutical Section , Section on Statistical Consulting , Statistics in Business Schools Interest Group
Organizer(s): Vipin Arora, Eli Lilly and Company
Chair(s): Vipin Arora, Eli Lilly and Company
8:35 AM	Statistical Programmers - New Brand of Leaders
Panelists:	Nebiyou Bekele, Gilead Sciences Pandu Kulkarni, Eli Lilly and Company Paul Schuette, FDA CDER Jonathan Lisic, USDA/NASS Steven Kirby, Chiltren
10:10 AM	Floor Discussion

287 * !	Tue, 8/1/2017, 8:30 AM - 10:20 AM	CC-331/332
Characterizing Clinical Dose Response Studies — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Anindita Banerjee, Pfizer, Inc.
Chair(s): Anindita Banerjee, Pfizer, Inc.
8:35 AM	Characterizing Clinical Dose Response Studies — Neal Thomas, Pfizer ; Joseph Wu, Pfizer, Inc.
8:55 AM	Clinical Dose-Response for a Broad Set of Biological Products: a Model-Based Meta-Analysis — Joseph Wu, Pfizer, Inc. ; Anindita Banerjee, Pfizer, Inc. ; Bo Jin, Pfizer, Inc. ; Sandeep Menon, Pfizer, Inc ; Steven W Martin, Pfizer, Inc. ; Anne C Heatherington, Pfizer, Inc.
9:15 AM	Exact Tests of Monotonic and Umbrella-Ordered Dose-Response for Binary Outcomes — William Brady, Roswell Park Cancer Institute
9:35 AM	Discussant: Naitee Ting, Boehringer Ingelheim
9:55 AM	Discussant: Sandeep Menon, Pfizer, Inc
10:15 AM	Floor Discussion

291	Tue, 8/1/2017, 8:30 AM - 10:20 AM	CC-322
SPEED: Biopharmaceutical Statistics — Contributed Speed
Biopharmaceutical Section , Section on Statistical Learning and Data Science
Chair(s): Veronica L. Powell, QST Consultations
8:35 AM	Tradeoffs of a Randomize, Then Consent Approach to Improving Cluster Participation Rates in Cluster Randomize Trials — Abigail Shoben, The Ohio State University
8:40 AM	Sample Size for Joint Testing Cause-Specific Hazard and Overall Hazard in the Presence of Competing Risks — Qing Yang, Duke University ; Gang Li, University of California, Los Angeles
8:45 AM	Accounting for Baseline Covariates and Missing Data in Regulatory Trials with Longitudinal Designs — Elizabeth Colantuoni, Johns Hopkins University ; Jon Steingrimsson, Johns Hopkins University ; Aidan McDermott, Johns Hopkins University ; Michael Rosenblum, Johns Hopkins University
8:50 AM	Robust Feature Selection and Cell Line Classification with Electric Cell-Substrate Impedance Sensing Data — Megan Gelsinger, Cornell University ; David S Matteson, Cornell University ; Laurie Tupper, Williams College
8:55 AM	Comparing Biomarker-Guided Treatment Strategies Using Local Posterior Predictive Benefit — Meilin Huang, The University of Texas MD Anderson Cancer Center ; Brian P. Hobbs, The University of Texas MD Anderson Cancer Center
9:00 AM	A Comparison of Assay Platforms Using Correlation Coefficients in the Presence of Repeated Measurements — Qinlei Huang, Merck & Co. ; Radha Railkar, Merck & Co. ; Anita Lee, Merck & Co.
9:10 AM	On Measure of Surrogacy for Biomarkers in Medical Research. — Rui Zhuang, University of Washington ; Ying Qing Chen, Fred Hutchinson Cancer Research Center
9:15 AM	Discriminant Analysis (DA) Based Methods in Safety Evaluation — Angang Zhang, Merck ; Richard Baumgartner, Merck ; William W Wang, Merck & Co Inc
9:20 AM	On the Estimation of Risk Difference in the Presence of Continuous Baseline Covariates — Hua Ma, Merck ; Robin Mogg, Merck
9:30 AM	Power Comparison of Tests of Restricted Mean Survival Time with Log-Rank Test and Generalized Wilcoxon Test Under Various Survival Distributions — Musashi Fukuda, Astellas Pharma Inc. ; Yutaka Matsuyama, Department of Biostatistics, School of Public Health, The University of Tokyo
9:35 AM	Optimal Designs for Pharmacokinetic Studies Analyzed Using Non-Compartmental Methods — Helen Barnett, Lancaster University ; Thomas Jaki, Lancaster University ; Helena Geys, Janssen Pharmaceutica ; Tom Jacobs, Janssen Pharmaceutica
9:40 AM	Statistical Considerations in Delayed-Start Design to Demonstrate Disease Modification Effect in Neurodegenerative Disorders — Jun Zhao, AbbVie Inc. ; Deli Wang, AbbVie, Inc. ; Weining Z Robieson, AbbVie Inc.
9:45 AM	Placebo-Based Multiple Imputation Methods for Sensitivity Analysis in Recurrent Event Data — Rui Yang, Chiltern International Inc
9:50 AM	Sample Size Calculation for the Generalized Poisson Regression Model Comparing Two Rates of Recurrent Events — Kimitoshi Ikeda, Amgen Astellas BioPharma K.K.
9:55 AM	Sample Size Calculation to Support Local Submission — Zhuqing Yu, AbbVie ; Bidan Huang, AbbVie ; Jun Zhao, AbbVie Inc. ; lu cui, Abbvie
10:00 AM	An Examination of the Association Between Alcohol and Dementia in a Longitudinal Study — Tingting Hu, Florida State University ; Dan McGee, Florida State University ; Elizabeth Slate, Florida State University
10:05 AM	Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products — Meiyu Shen, C DER, FDA ; Lixin Xu, FDA
10:15 AM	Floor Discussion

295 * !	Tue, 8/1/2017, 8:30 AM - 10:20 AM	CC-336
Adaptive Designs and Interim Analyses — Contributed Papers
Biopharmaceutical Section
Chair(s): John Han, Johnson & Johnson
8:35 AM	Tests and Classifications in Adaptive Designs with Applications — Qiusheng Chen, Florida State University ; Xufeng Niu, Florida State University
8:50 AM	A Two-Stage Design for Phase III Trials with Population Selection — Wen Li, Merck & Co. Inc.
9:05 AM	A Practical Bayesian Adaptive Design with Application to Cardiovascular Outcomes Trials — Matthew Psioda, UNC Chapel Hill ; Joseph G Ibrahim, UNC ; Mat Soukup, Center for Drug Evaluation and Research, Office of Translational Sciences, FDA
9:20 AM	Earning Regulatory Approval for a Phase II/III Design: a Case Study from Start to Finish — Adam Hamm, Cytel, Inc.
9:35 AM	Adaptive Designs in Phase II Basket Clinical Trials — Kristen Cunanan ; Alexia Iasonos, Memorial Sloan Kettering Sloan Cancer Center ; Ronglai Shen, Memorial Sloan Kettering Cancer Center ; Colin Begg, Memorial Sloan Kettering Cancer Center ; Mithat Gonen, Memorial Sloan Kettering Cancer Center
10:05 AM	A Curtailed Procedure for Comparing Treatments with Binary Response with a Control — Pinyuen Chen, Syracuse University ; Lifang Hsu, Le Moyne College

CE_22C	Tue, 8/1/2017, 8:30 AM - 5:00 PM	H-Holiday Ballroom 5
Analysis of Clinical Trials: Theory and Applications (ADDED FEE) — Professional Development Continuing Education Course
ASA , Biopharmaceutical Section
Instructor(s): Devan Mehrotra, Merck & Co. Inc. , Alex Dmitrienko, Mediana Inc, Jeff Maca, Quintiles
8:30 AM	Analysis of Clinical Trials: Theory and Applications (ADDED FEE) — Devan Mehrotra, Merck & Co. Inc. ; Alex Dmitrienko, Mediana Inc ; Jeff Maca, Quintiles

320 *	Tue, 8/1/2017, 10:30 AM - 12:20 PM	CC-318
The New ICH Guideline on Estimands: An Academic Perspective — Invited Panel
ENAR , WNAR , Biopharmaceutical Section
Organizer(s): Frank Bretz, Novartis AG, Estelle Russek-Cohen, U.S. Food and Drug Administration
Chair(s): Geert Molenberghs , Universiteit Hasselt
10:35 AM	The New ICH Guideline on Estimands: An Academic Perspective
Panelists:	Eric Tchetgen Tchetgen, Harvard University Estelle Russek-Cohen, U.S. Food and Drug Administration Scott Emerson, University of Washington Susan Ellenberg, University of Pennsylvania T. Shun Sato, University of Kyoto
12:10 PM	Floor Discussion

328 *	Tue, 8/1/2017, 10:30 AM - 12:20 PM	CC-314
New Guidance on Specifying the Target Difference (Effect Size) for a Randomised Controlled Trial — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Steven Julious, University of Sheffield
Chair(s): Steve Snapinn, Amgen
10:35 AM	The Impact of the Treatment Effect on Sample Size Estimation — Jerry Hintze, NCSS
10:55 AM	Achieving Consensus on Guidance for Specifying the Target Difference in a RCT Sample Size Calculation - DELTA2 Project — William Sones, University of Oxford ; Jonathan Cook, University of Oxford
11:15 AM	A Review of the Sample Size Calculations of Randomised Controlled Trials Funded by One of the Leading Funders in the UK — Steven Julious, University of Sheffield ; Jo Rothwell, University of Sheffield
11:35 AM	New DELTA2 Guidance on Specifying the Target Difference in a RCT Sample Size Calculation — Jonathan Cook, University of Oxford
11:55 AM	Discussant: Byron Jones, Novartis
12:15 PM	Floor Discussion

331 * !	Tue, 8/1/2017, 10:30 AM - 12:20 PM	CC-327
Quantitative Safety Monitoring: Regulatory Landscape, Statistical Methodology, and Cross-Disciplinary Scientific Engagement — Topic Contributed Panel
Biopharmaceutical Section , Society for Clinical Trials , Biometrics Section
Organizer(s): Greg Ball, Merck
Chair(s): Judy X. Li, Regeneron Pharmaceuticals
10:35 AM	Quantitative Safety Monitoring: Regulatory Landscape, Statistical Methodology and Cross-Disciplinary Scientific Engagement
Panelists:	Greg Ball, Merck Frank Rockhold, Retired Janet Wittes, Statistics Collaborative, Inc. (SCI) Ana Szarfman, CDER, FDA William W Wang, Merck & Co Inc
12:10 PM	Floor Discussion

333	Tue, 8/1/2017, 10:30 AM - 12:20 PM	CC-323
SPEED: Biopharmaceutical Statistics, Medical Devices, and Mental Health — Contributed Speed
Biopharmaceutical Section , Section on Medical Devices and Diagnostics , Mental Health Statistics Section , Social Statistics Section , International Indian Statistical Association
Chair(s): Abie Ekangaki, UCB Biopharma SPRL
10:35 AM	Missing Data Imputation Strategies for Different Estimands in Clinical Trials — Ye Tan, Pfizer ; Steven Gilbert, Pfizer Inc.
10:40 AM	A Case Study Evaluating Time Varying Covariate and Competing Risk for Efficacy Evaluation in Survival Analyses — Yang Xu, BioStat Solutions, Inc.
10:50 AM	Subgroup Analyzes with Survival Data in Retrospective Cohort Studies — Rima Izem, Food and Drug Administration ; Jiemin Lao, Sphere Institute ; Mao Hu, Acumen LLC ; Yuqin Wei, Sphere Institute ; Michael Wernecke, Acumen LLC ; Jeffrey A Kelman, Centers for Medicaid and Medicare Services (CMS) ; David J Graham, Food and Drug Administration
10:55 AM	Social Media and Clinical Trials — Darcy Hille, Merck ; T. Ceesay, Merck & Co, Inc.
11:00 AM	Propensity Score Methods for Analysis Time-To-Event Data — Haiying Lin
11:05 AM	Modeling Transcranial Magnetic Stimulation-Driven Stimulus-Response Curves — Caitlin I. Steiner, Department of Statistics, University of Virginia ; Sahana N. Kukke, Department of Biomedical Engineering, The Catholic University of America ; Nivethida Thirugnanasambandam, Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological ; Mark Hallett, Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological ; Daniel M. Keenan, Department of Statistics, University of Virginia
11:10 AM	Parsimonious Modeling for Kinematic Data — Md Islam, North Carolina State University ; Jonathan W. Stallings, North Carolina State University
11:20 AM	Developing a Performance Sustaining Decoder for a Brain Computer Interface Controlled Neuroprosthetic Device — David Friedenberg, Battelle Memorial Institute ; Mingming Zhang, Battelle ; Michael Schwemmer, Battelle ; Nick Annetta, Battelle ; Marcia Bockbrader, Center for Neuromodulation, The Ohio State University & Department of Physical Medicine an ; Chad Bouton, Battelle (currently at Feinstein Institute for Medical Research) ; Ali Rezai, Center for Neuromodulation, The Ohio State University ; W. Jerry Mysiw, Department of Physical Medicine and Rehabilitation, The Ohio State University ; Herbert Bresler, Battelle ; Gaurav Sharma, Battelle
11:25 AM	Combining Different Data Sources in Accelerometry Study — Jiawei Bai, Johns Hopkins University ; Chongzhi Di, Fred Hutchinson Cancer Research Center ; Ciprian M Crainiceanu, Johns Hopkins University
11:30 AM	Repeated Cross-Sectional Surveys: Accounting for Instrumentation Changes — John Bunker, RTI International ; Marcus Berzofsky, RTI International
11:35 AM	Survival Analysis on a Social Network — SONG Fangda, The Chinese University of Hong Kong ; Yingying Wei, The Chinese University of Hong Kong
11:40 AM	Social Network Impact on Family Planning Use in Benin — Theresa Y Kim, Maryland Population Research Center ; Kimberly A Ashburn, Elizabeth Glaser Pediatric AIDS Foundation ; Rebecka I Lundgren, Institute for Reproductive Health, Georgetown University ; Susan M Igras, Institute for Reproductive Health, Georgetown University
11:45 AM	Assessing the Combination of Evidence Through a Probabilistic Graphical Model — Amanda Luby, Carnegie Mellon University ; Anjali Mazumder, Carnegie Mellon University
11:50 AM	Identifying Latent Structures in Restricted Latent Class Models — Zhuoran Shang, University of Minnesota ; Gongjun Xu, University of Michigan
11:55 AM	On the Hazard Function of Kumaraswamy Distribution and Associated Inference — Rajarshi Dey, University of South Alabama ; Nutan Mishra, University of south alabama
12:00 PM	Floor Discussion

337 * !	Tue, 8/1/2017, 10:30 AM - 12:20 PM	CC-315
Interim Monitoring and Analyses: Two-Stage, Multi-Stage, and Group Sequential Designs — Contributed Papers
Biopharmaceutical Section
Chair(s): Mike Henderson, SAS
10:35 AM	Decision of Performing Interim Analysis for Comparative Clinical Trials — Kyongsun Pak, Kitasato University ; Susanna Jacobus, Dana Farber Cancer Institute ; Hajime Uno, Dana Farber Cancer Institute
10:50 AM	The Three Keys to Having Effective Interim Review Data Monitoring Committee Meetings for Clinical Trials — Navneet Hakhu, Axio Research
11:05 AM	Determination of Interim Go/No-Go Criteria with Simulations of Longitudinal Continuous Data in a Phase 2 Clinical Trial of a Neurodegenerative Disorder — Weining Z Robieson, AbbVie Inc. ; Greg Cicconetti, Abbvie ; Deli Wang, AbbVie, Inc.
11:20 AM	Robust Inference for Group Sequential Trials — Jitendra Ganju ; Yunzhi Lin, AbbVie ; Kefei Zhou, Theravance
11:35 AM	Strategies in Designing Interim Analyzes Under Discrete Random-Effects Model in a Multiregional Trial — Hsiao-Hui Tsou, National Health Research Institutes ; Chi-Tian Chen, National Health Research Institutes ; K. K. Gordon Lan, Janssen Pharmaceutical Companies of Johnson & Johnson ; Chin-Fu Hsiao, National Health Research Institutes
11:50 AM	Multi-Arm Multi-Stage Group Sequential Design in Clinical Trial — Pranab Ghosh, Cytel Inc, Boston University ; Cyrus Mehta, Cytel Inc
12:05 PM	Extension of the Two-Stage Randomized Trial Design for Testing Treatment, Self-Selection, and Treatment Preference Effects to Binary Outcomes — Briana Cameron, Yale University ; Denise Esserman, Yale School of Public Health ; Peter Peduzzi, Yale School of Public Health

357	Tue, 8/1/2017, 10:30 AM - 11:15 AM	CC-Halls A&B
SPEED: Biopharmaceutical Statistics — Contributed Poster Presentations
Biopharmaceutical Section , Section on Statistical Learning and Data Science
Chair(s): Jessi Cisewski, Yale University
1:	Tradeoffs of a Randomize, Then Consent Approach to Improving Cluster Participation Rates in Cluster Randomize Trials — Abigail Shoben, The Ohio State University
2:	Sample Size for Joint Testing Cause-Specific Hazard and Overall Hazard in the Presence of Competing Risks — Qing Yang, Duke University ; Gang Li, University of California, Los Angeles
3:	Accounting for Baseline Covariates and Missing Data in Regulatory Trials with Longitudinal Designs — Elizabeth Colantuoni, Johns Hopkins University ; Jon Steingrimsson, Johns Hopkins University ; Aidan McDermott, Johns Hopkins University ; Michael Rosenblum, Johns Hopkins University
4:	Robust Feature Selection and Cell Line Classification with Electric Cell-Substrate Impedance Sensing Data — Megan Gelsinger, Cornell University ; David S Matteson, Cornell University ; Laurie Tupper, Williams College
5:	Comparing Biomarker-Guided Treatment Strategies Using Local Posterior Predictive Benefit — Meilin Huang, The University of Texas MD Anderson Cancer Center ; Brian P. Hobbs, The University of Texas MD Anderson Cancer Center
6:	A Comparison of Assay Platforms Using Correlation Coefficients in the Presence of Repeated Measurements — Qinlei Huang, Merck & Co. ; Radha Railkar, Merck & Co. ; Anita Lee, Merck & Co.
8:	On Measure of Surrogacy for Biomarkers in Medical Research. — Rui Zhuang, University of Washington ; Ying Qing Chen, Fred Hutchinson Cancer Research Center
9:	Discriminant Analysis (DA) Based Methods in Safety Evaluation — Angang Zhang, Merck ; Richard Baumgartner, Merck ; William W Wang, Merck & Co Inc
10:	On the Estimation of Risk Difference in the Presence of Continuous Baseline Covariates — Hua Ma, Merck ; Robin Mogg, Merck
11:	Power Comparison of Tests of Restricted Mean Survival Time with Log-Rank Test and Generalized Wilcoxon Test Under Various Survival Distributions — Musashi Fukuda, Astellas Pharma Inc. ; Yutaka Matsuyama, Department of Biostatistics, School of Public Health, The University of Tokyo
12:	Optimal Designs for Pharmacokinetic Studies Analyzed Using Non-Compartmental Methods — Helen Barnett, Lancaster University ; Thomas Jaki, Lancaster University ; Helena Geys, Janssen Pharmaceutica ; Tom Jacobs, Janssen Pharmaceutica
13:	Statistical Considerations in Delayed-Start Design to Demonstrate Disease Modification Effect in Neurodegenerative Disorders — Jun Zhao, AbbVie Inc. ; Deli Wang, AbbVie, Inc. ; Weining Z Robieson, AbbVie Inc.
14:	Placebo-Based Multiple Imputation Methods for Sensitivity Analysis in Recurrent Event Data — Rui Yang, Chiltern International Inc
15:	Sample Size Calculation for the Generalized Poisson Regression Model Comparing Two Rates of Recurrent Events — Kimitoshi Ikeda, Amgen Astellas BioPharma K.K.
16:	Sample Size Calculation to Support Local Submission — Zhuqing Yu, AbbVie ; Bidan Huang, AbbVie ; Jun Zhao, AbbVie Inc. ; lu cui, Abbvie
17:	An Examination of the Association Between Alcohol and Dementia in a Longitudinal Study — Tingting Hu, Florida State University ; Dan McGee, Florida State University ; Elizabeth Slate, Florida State University
18:	Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products — Meiyu Shen, C DER, FDA ; Lixin Xu, FDA
The Speed portion will take place during Session 214526

361	Tue, 8/1/2017, 12:30 PM - 1:50 PM	CC-Ballroom II
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Qi Jiang, Amgen Inc.
TL09:	Benefit-Risk Analysis in Medical Development — Shuai Yuan, Merck
TL10:	Dose Finding in Oncology Trials: a Discussion on Challenges and Current Methods — Zhao Yang, Amgen, Inc.
TL11:	FDA/Industry-Wide Recommended Analyzes and Displays: a Vision Within Reach — Sheryl Treichel, Amgen
TL12:	Integrating Data Science and Big Data Concepts and Machine Learning in Drug Safety — Melvin Munsaka, Safety Statistics and Observational Res Analytics, Takeda
TL13:	Personalized Endpoints — Marian Strazzeri, US Food and Drug Administration

375 * !	Tue, 8/1/2017, 2:00 PM - 3:50 PM	CC-349
Negative Results: They're Essential! — Invited Papers
Committee on Professional Ethics , Biopharmaceutical Section , Section on Teaching of Statistics in the Health Sciences , Section for Statistical Programmers and Analysts
Organizer(s): Rochelle E Tractenberg, Georgetown University
Chair(s): Michael Brewster Hawes, U.S. Department of Education
2:05 PM	Negative Findings in Environmental Epidemiology — Sidney Stanley Young, CGStat
2:35 PM	Big effects of negative results in Big Data: classification errors with differential effects arise from unmodeled latent classes in value-added modeling — Futoshi Yumoto, Collaborative for Research on Outcomes and Metrics; Comcasts ; Rochelle E Tractenberg, Georgetown University
3:05 PM	Peer Review and Publication of Negative Results: Encouraging Rigor, Reproducibility, and the Integrity of the Scientific Record — Rochelle E Tractenberg, Georgetown University
	Discussant: John PA Ioannidis, Stanford University School of Medicine
3:35 PM	Floor Discussion

382	Tue, 8/1/2017, 2:00 PM - 3:50 PM	CC-308
Improving the Efficiency of Medical Device Clinical Trials by Combining Simulations and Experiments — Invited Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section , Society for Medical Decision Making
Organizer(s): Rajesh Nair, FDA/CDRH/OSB/DBS
Chair(s): Tarek Haddad, Medtronic Cardiac Rhythm and Heart Failure
2:05 PM	The Past Is Prologue: The Use of Prior Information and Bayesian Methodologies in Designing Medical Device Regulatory Approval Trial — Roseann White, Pragmatic clinical trial Statistics, Duke Clinical Research Institute
2:20 PM	Incorporation of Stochastic Engineering Models as Prior Information in Bayesian Medical Device Trials — Valentin Parvu, BDX Corporate/Shared services, BD
2:35 PM	Discussant: Telba Irony, Office of Biostatistics and Epidemiology, CBER, FDA
2:50 PM	Discussant: Kyle Myers, Office of Science and Engineering Laboratories, CDRH
3:05 PM	Discussant: Scott Evans, Harvard University
3:20 PM	Discussant: Greg Campbell, GC stat consulting and former Director DBS/CDRH
3:35 PM	Floor Discussion

386 * !	Tue, 8/1/2017, 2:00 PM - 3:50 PM	CC-341
Estimands: What Is Essential Is Invisible to the Eye — Invited Papers
Biopharmaceutical Section , ENAR , Biometrics Section
Organizer(s): Mouna Akacha , Novartis Pharma AG
Chair(s): Joan Buenconsejo, AstraZeneca
2:05 PM	A Dialogue on Estimands — Stephen J Ruberg, Eli Lilly and Co
2:25 PM	Defining estimands in pain studies — Paul Gallo, Novartis
2:45 PM	Application of the Tripartite Estimands in a Diabetes Clinical Trial — Junxiang Luo, Eli Lilly and Company ; Yongming Qu, Eli Lilly and Company ; Stephen J Ruberg, Eli Lilly and Co
3:05 PM	Causal Estimands in Randomized Trials — Miguel Hernan, Harvard TH Chan School of Public Health
3:25 PM	Discussant: Gregory Levin, FDA
3:45 PM	Floor Discussion

392 *	Tue, 8/1/2017, 2:00 PM - 3:50 AM	CC-327
What Do the Experts Believe? Leveraging Expert Knowledge to Develop Robust Informative Prior Belief Distributions to Aid Decision Making in Drug and Medical Device Development — Topic Contributed Papers
Section on Bayesian Statistical Science , Biopharmaceutical Section
Organizer(s): Timothy H Montague, GlaxoSmithKline
Chair(s): Karen Price, Eli Lilly
2:05 PM	What Do the Experts Believe? Translating Expert Knowledge and Judgment into a Quantitative Belief Distribution — Timothy H Montague, GlaxoSmithKline
2:25 PM	Expert Prior Elicitations in Practice — Michael Sonksen, Eli Lilly and Company
2:45 PM	Eliciting Priors and Tradeoffs to Assist in the Design of Clinical Studies — Joseph Kahn, Novartis Pharmaceuticals
3:05 PM	glmcmp: Generalized Linear Models with Conditional Means Priors in R — David Kahle, Baylor University ; James Stamey, Baylor University ; Michael Sonksen, Eli Lilly and Company ; Michael W. Seaman, Jr., Baylor University ; Karen Price, Eli Lilly ; Fanni Natanegara, Eli Lilly and Company
5:25 PM	Discussant: Shabnam Azadeh, Center for Devices and Radiological Health, FDA
3:45 PM	Floor Discussion

398 *	Tue, 8/1/2017, 2:00 PM - 3:50 PM	CC-346
Different Approaches to the Increase of a Sample Size When the Unblinded Interim Estimate of the Treatment Effect Looks Promising — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Mikhail Peter Salganik, Pfizer Worldwide Research & Development, Pfizer, Inc
Chair(s): Sandeep Menon, Pfizer, Inc
2:05 PM	An Evaluation of Increasing Sample Size Based on Conditional Power — Michael Gaffney, Pfizer Inc.
2:25 PM	Efficiency Considerations for Group Sequential Designs with Adaptive Unblinded Sample Size Re-Assessment — Sam Hsiao, Cytel, Inc ; Lingyun Liu, Cytel, Inc ; Cyrus Mehta, Cytel Inc
2:45 PM	Extensions of Adaptive Sample Size Re-Estimation Methods to the Negative Binomial Setting — Mikhail Peter Salganik, Pfizer Worldwide Research & Development, Pfizer, Inc ; Sandeep Menon, Pfizer, Inc ; Abigail Sloan, Harvard T.H. Chan School of Public Health
3:05 PM	Adapting the 5-Zone Adaptive Design — Yi Liu, Takeda ; Mingxiu Hu, Takeda Pharmaceutical
3:25 PM	Implementation of Promising Zone Methodology in a Ph 3 Trial in AML (VALOR) — Jennifer Smith, Sunesis
3:45 PM	Floor Discussion

401 * !	Tue, 8/1/2017, 2:00 PM - 3:50 PM	CC-344
Multiple Measures and Multiple Testing — Contributed Papers
Biopharmaceutical Section
Chair(s): Ghideon Solomon, FDA
2:05 PM	The Cost of Comparing Survival Curves Using Multiple Measures — Godwin Yung, Takeda Pharmaceutical ; Yi Liu, Takeda ; Mingxiu Hu, Takeda Pharmaceutical
2:20 PM	Multiple Testing Procedures in Group Sequential Designs: Comparing Methods and New Proposals — Man Jin, Merck Research
2:35 PM	Multiplicity Adjustment Approaches in Multiple Endpoint Study with Group Sequential Designs — Sunhee Ro ; Muhtar Osman, Amgen
2:50 PM	A New Solution to Gate-Keeping Problems in Multiple Hypothesis Testing — Huajiang Li, Avanir Pharmaceuticals ; Hong Zhou, Arkansas State University
3:05 PM	A New Graphical Approach with Generalized Sequential Rejection Principle to Control the Familywise Error Rate — Li Yu, New Jersey Institute of Technology ; Wenge Guo, New Jersey Institute of Technology ; Zhiying Qiu, Sanofi
3:20 PM	A Selective Inference-Based Two-Stage Procedure for Clinical Safety Studies — Yalin Zhu, New Jersey Institute of Technology ; Wenge Guo, New Jersey Institute of Technology
3:35 PM	Floor Discussion

423	Tue, 8/1/2017, 2:00 PM - 2:45 PM	CC-Halls A&B
SPEED: Biopharmaceutical Statistics, Medical Devices, and Mental Health — Contributed Poster Presentations
Biopharmaceutical Section , Section on Medical Devices and Diagnostics , Mental Health Statistics Section , International Indian Statistical Association , Social Statistics Section
Chair(s): Jessi Cisewski, Yale University
21:	Missing Data Imputation Strategies for Different Estimands in Clinical Trials — Ye Tan, Pfizer ; Steven Gilbert, Pfizer Inc.
22:	A Case Study Evaluating Time Varying Covariate and Competing Risk for Efficacy Evaluation in Survival Analyses — Yang Xu, BioStat Solutions, Inc.
24:	Subgroup Analyzes with Survival Data in Retrospective Cohort Studies — Rima Izem, Food and Drug Administration ; Jiemin Lao, Sphere Institute ; Mao Hu, Acumen LLC ; Yuqin Wei, Sphere Institute ; Michael Wernecke, Acumen LLC ; Jeffrey A Kelman, Centers for Medicaid and Medicare Services (CMS) ; David J Graham, Food and Drug Administration
25:	Social Media and Clinical Trials — Darcy Hille, Merck ; T. Ceesay, Merck & Co, Inc.
26:	Propensity Score Methods for Analysis Time-To-Event Data — Haiying Lin
27:	Modeling Transcranial Magnetic Stimulation-Driven Stimulus-Response Curves — Caitlin I. Steiner, Department of Statistics, University of Virginia ; Sahana N. Kukke, Department of Biomedical Engineering, The Catholic University of America ; Nivethida Thirugnanasambandam, Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological ; Mark Hallett, Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological ; Daniel M. Keenan, Department of Statistics, University of Virginia
28:	Parsimonious Modeling for Kinematic Data — Md Islam, North Carolina State University ; Jonathan W. Stallings, North Carolina State University
29:	Developing a Performance Sustaining Decoder for a Brain Computer Interface Controlled Neuroprosthetic Device — David Friedenberg, Battelle Memorial Institute ; Mingming Zhang, Battelle ; Michael Schwemmer, Battelle ; Nick Annetta, Battelle ; Marcia Bockbrader, Center for Neuromodulation, The Ohio State University & Department of Physical Medicine an ; Chad Bouton, Battelle (currently at Feinstein Institute for Medical Research) ; Ali Rezai, Center for Neuromodulation, The Ohio State University ; W. Jerry Mysiw, Department of Physical Medicine and Rehabilitation, The Ohio State University ; Herbert Bresler, Battelle ; Gaurav Sharma, Battelle
30:	Combining Different Data Sources in Accelerometry Study — Jiawei Bai, Johns Hopkins University ; Chongzhi Di, Fred Hutchinson Cancer Research Center ; Ciprian M Crainiceanu, Johns Hopkins University
31:	Repeated Cross-Sectional Surveys: Accounting for Instrumentation Changes — John Bunker, RTI International ; Marcus Berzofsky, RTI International
32:	Survival Analysis on a Social Network — SONG Fangda, The Chinese University of Hong Kong ; Yingying Wei, The Chinese University of Hong Kong
33:	Social Network Impact on Family Planning Use in Benin — Theresa Y Kim, Maryland Population Research Center ; Kimberly A Ashburn, Elizabeth Glaser Pediatric AIDS Foundation ; Rebecka I Lundgren, Institute for Reproductive Health, Georgetown University ; Susan M Igras, Institute for Reproductive Health, Georgetown University
34:	Assessing the Combination of Evidence Through a Probabilistic Graphical Model — Amanda Luby, Carnegie Mellon University ; Anjali Mazumder, Carnegie Mellon University
35:	Identifying Latent Structures in Restricted Latent Class Models — Zhuoran Shang, University of Minnesota ; Gongjun Xu, University of Michigan
36:	On the Hazard Function of Kumaraswamy Distribution and Associated Inference — Rajarshi Dey, University of South Alabama ; Nutan Mishra, University of south alabama
The Speed portion will take place during Session 214535

214675	Tue, 8/1/2017, 5:30 PM - 7:30 PM	H-Key Ballroom 5
Biopharmaceutical Section Mixer and Open Business Meeting — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Alex Dmitrienko, Mediana Inc

438 * !	Wed, 8/2/2017, 8:30 AM - 10:20 AM	CC-308
Real-World Evidence in Clinical Trial: New Era of Informed Decision Making Session — Invited Papers
Biopharmaceutical Section , Health Policy Statistics Section , Society for Medical Decision Making , Section on Medical Devices and Diagnostics
Organizer(s): Satrajit Roychoudhury, Pfizer Inc
Chair(s): Margaret Gamalo-Siebers, Eli Lilly
8:35 AM	Real World Evidence to Support Accelerated Approval Processes — Sebastian Schneeweiss, Harvard Medical School ; Jessica Franklin, Harvard Medical School
9:00 AM	Assessing the impact of informative censoring on overall survival in a RWD source. — Bill Capra, Genentech Inc. ; Gillis Carrigan, Genentech Inc. ; Michael Taylor, Genentech Inc. ; Brandon Arnieri, Genentech Inc. ; Melissa Curtis, Flatiron Health ; Sandy Griffith, Flatiron Health ; Aracelis Torres, Flatiron Health ; Philip Hofmeister, Flatiron Health ; Anala Gossai, Flatiron Health ; Samuel Whipple, Genentech Inc ; Peter Lambert, Genentech Inc
9:25 AM	Statistical Design Considerations for Utilizing Real World Data in Premarket Evaluation of Medical Devices — Yunling Xu, CDRH/FDA ; Nelson Lu, CDRH/FDA ; Lilly Yue, Division of Biostatistics, CDRH/ U.S. FDA ; Ram Tiwari, FDA/CDRH
9:50 AM	Discussant: Douglas E Faries, Eli Lilly
10:15 AM	Floor Discussion

451 * !	Wed, 8/2/2017, 8:30 AM - 10:20 AM	CC-303
Current Trends in Statistical Genomics: Finding Needle in a Haystack? — Topic Contributed Papers
ENAR , Biopharmaceutical Section , International Indian Statistical Association , Section on Statistics in Genomics and Genetics
Organizer(s): Somnath Datta, University of Florida
Chair(s): Hyoyoung Choo-Wosoba, NCI, NIH
8:35 AM	Marginal False Discovery Rates for Penalized Regression Models — Patrick Breheny, University of Iowa
8:55 AM	Advances and Challenges of Single Cell RNA-Seq Data Analysis — Susmita Datta, University of Florida
9:15 AM	Statistical Challenges in Analysis of Complex Phenotypes Derived from Sequential Images — Dan Nettleton, Iowa State University ; Patrick Schnable, Iowa State University ; Yehua Li, Iowa State University ; Li Wang, Iowa State University ; Baskar Ganapathysubramanian, Iowa State University
9:35 AM	ANOVA-Based Clustering to Improve Potency Estimation in Quantitative High-Throughput Screening Data — Shyamal Peddada, NIH/NIEHS ; Keith Shockley, NIEHS ; Abhishek Kaul, NIEHS ; Shuva Gupta, UC Davis ; Shawn Harris, SSS ; Soumendra N Lahiri, North Carolina State University
9:55 AM	Association Analysis Using Sequence Reads Without Calling Genotypes — Yijuan Hu, Emory University ; Peizhou Liao, Department of Biostatistics and Bioinformatics, Emory ; Henry Johnston, Department of Biostatistics and Bioinformatics, Emory ; Andrew Allen, Department of Biostatistics and Bioinformatics, Duke ; Glen Satten, Centers for Disease Control and Prevention
10:15 AM	Floor Discussion

458 * !	Wed, 8/2/2017, 8:30 AM - 10:20 AM	CC-319
New Challenges in Subgroup Analyses and Enrichment Designs — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Frank Bretz, Novartis AG
Chair(s): Rosanne Lane, Janssen Research & Development, LLC
8:35 AM	Identification of Subgroups with Heterogeneous Treatment Effect in Dose-Response Studies — Bjorn Bornkamp, Novartis Pharma AG ; Marius Thomas, Novartis
8:55 AM	Improving Subgroup Identification: Type I Error Control, Power, and the Quality of Subgroups — Lei Shen, Eli Lilly and Company
9:15 AM	Sample Size Calculation in Confirmatory Subgroup Analyses — Dong Xi, Novartis Pharmaceuticals Corporation ; Frank Bretz, Novartis AG ; Ekkehard Glimm, Novartis
9:35 AM	Stochastic Optimization of Adaptive Enrichment Designs for Two Subpopulations — Michael Rosenblum, Johns Hopkins University ; Aaron Fisher, Harvard University-Department of Biostatistics ; Joshua A Betz, Johns Hopkins University ; Jon Steingrimsson, Johns Hopkins University
9:55 AM	Estimand in Evaluating Predictive or Selection Markers Using Enrichment Design in Clinical Trials — Jingjing Ye, FDA
10:15 AM	Floor Discussion

467 * !	Wed, 8/2/2017, 8:30 AM - 10:20 AM	CC-315
Bayesian Methods and Applications in Clinical Trials (II) — Contributed Papers
Biopharmaceutical Section
Chair(s): Xiaoling Wu, Celgene Corporation
8:35 AM	BOP2: Bayesian Optimal Designs for Phase II Clinical Trials with Simple and Complex Endpoints — Heng Zhou, MD Anderson Cancer Center ; Ying Yuan, M.D. Anderson Cancer Center
8:50 AM	BAYESIAN PROBABILITY of SUCCESS for MULTIPLE CLINICAL TRIALS in CONTINUOUS OUTCOMES — Junnosuke Matsushima, Chugai Pharma USA
9:05 AM	Increasing Efficiency of Oncology Basket Trials Using a Bayesian Approach — Zheyu Liu, The University of Texas Health Science Center at Houston ; Rong Liu, Bayer Healthcare ; Mercedeh Ghadessi, Bayer Healthcare ; Richardus.vonk Vonk, Bayer Healthcare
9:20 AM	Bayesian Design for Interim Analysis — Dung-Tsa Chen, Moffitt Cancer Center
9:50 AM	Practical Considerations for Designing Pediatric Trials — Jerry Weaver, Celgene
10:05 AM	Floor Discussion

493 * !	Wed, 8/2/2017, 10:30 AM - 12:20 PM	CC-329
Bayesian Model-Based and Rule-Based Dose Escalation Designs in Oncology — Topic Contributed Papers
Section on Bayesian Statistical Science , Biopharmaceutical Section
Organizer(s): Charles Liu, Cytel Inc.
Chair(s): Erik Pulkstenis, Medimmune
10:35 AM	A Case Study Exploration of MTPI and Proposed Methods to Expand to Combination Drug Development — Matthew Gribbin, MedImmune ; Nairouz Elgeioushi, MedImmune
10:55 AM	Alternative Dose Escalation Rules for Dual Agent Designs — Charles Liu, Cytel Inc. ; Yannis Jemiai, Cytel Inc. ; Sam Hsiao, Cytel, Inc ; Hrishikesh Kulkarni, Cytel Inc.
11:15 AM	Combination Dose Finding in Phase I Oncology Trials: a Co-Data Approach — Niladri Roy Chowdhury, Novartis Oncology Pharmaceuticals ; Satrajit Roychoudhury, Pfizer Inc
11:35 AM	Model-based Design for the Early Development of Cancer Immunotherapy Combinations — Nolan Wages, University of Virgina
11:55 AM	Discussant: Guan Xing, Gilead
12:15 PM	Floor Discussion

497 *	Wed, 8/2/2017, 10:30 AM - 12:20 PM	CC-315
Biopharm Safety Monitoring Working Group: Bayesian and Graphics Approaches Based on Regulatory Guidance — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Susan P Duke, Safety Statistics Consultant
Chair(s): Melvin Munsaka, Safety Statistics and Observational Res Analytics, Takeda
10:35 AM	Biopharm Safety Monitoring Working Group: Bayesian and Graphics Approaches Based on Regulatory Guidance — Kefei Zhou, Theravance Biopharma ; Melvin Munsaka, Safety Statistics and Observational Res Analytics, Takeda
10:55 AM	Analysis of Clinical Trial Adverse Event Data — Michael Fries, CSL Behring ; Judy X. Li, Regeneron Pharmaceuticals ; Matilde Sanchez-Kam
11:15 AM	When to Alert a Safety Assessment Committee - Approaches and Examples — Brian Waterhouse
11:35 AM	Discussant: Barbara Hendrickson, TA Head, Immunology, Pharmacovigilence and Patient Safety, AbbVie
11:55 AM	Discussant: Yong Ma, FDA/CDER/OTS/OB/DB VII
12:15 PM	Floor Discussion

505 * !	Wed, 8/2/2017, 10:30 AM - 12:20 PM	CC-320
Missing Data and Multiple Imputation in Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Oluyemi Oyeniran, Janssen
10:35 AM	Parameter Estimation Based on Stratified Cox Model with Missing Data of Stratified Factors in Small-Sized Trials or Small Strata — Junji Moriya, Kyowa Kirin Pharmaceutical Development, Inc.
10:50 AM	Fitting Proportional Odds Model with Missing Responses When the Missing Data Are Nonignorable — Vivek Pradhan, Pfizer Inc. ; Huaming Tan, Pfizer Inc
11:05 AM	A Practical Application of Multiple Imputation (MI) in a Double Blinded Randomized Phase III Study in Spinal Muscular Atrophy — Peng Sun, Biogen ; Richard Foster, Biogen ; Guochen Song, Biogen ; John Zhong, Biogen
11:20 AM	Missing Data - How Much Is Too Much ? — Lilianne (Lee-Lian) Kim, Janssen Pharmaceuticals R&D ; Kim Hung Lo, Janssen R&D, LLC
11:35 AM	Extending Multiple Imputation of a Clinical Trial Outcome to Nonparametric Methods — Kimberly Walters, Statistics Collaborative, Inc. ; Lisa Weissfeld, Statistics Collaborative, Inc.
11:50 AM	Subgroup Analyzes from Multiple Imputed Data Sets — Tianyue Zhou ; Zhiying Qiu, Sanofi ; Meehyung Cho, Sanofi ; Hui Quan, Sanofi
12:05 PM	Implementing Multiple Imputation in Non-Inferiority Clinical Trials — Brian Wiens, Tobira Therapeutics ; Ilya Lipkovich, QuintilesIMS

506 * !	Wed, 8/2/2017, 10:30 AM - 12:20 PM	CC-319
Statisticians' Approaches to the Realities of Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Faiz Ahmad, Head US Statistics, Galderma R&D
10:35 AM	Approaches to Analysis of Treatment Interruptions Among Cancer Patients on Oral Oncolytic Agents — Asish Banik, Michigan State University ; Charles W. Given, Michigan State University ; Barbara Given, Michigan State University ; Atreyee Majumder, Michigan State University ; Alla Sikorskii, University of Arizona ; Eric Vachon, Michigan State University
10:50 AM	Analysis of Dichotomous Binary Data with Missing Data Imputed Under Jump to Reference and Copy Reference Models — Zachary Zimmer, Merck ; Lei Xu, Merck ; Frank Liu, Merck & Co. Inc.
11:05 AM	Effective Use of Multiple Primary Endpoints and Composite Endpoints in Assessing Collective Evidence in Clinical Trials — George Kordzakhia, FDA ; Yeh-Fong Chen, US Food and Drug Administration
11:20 AM	Bias Reduction in Selection from Multiple Candidate Treatments — Jian Zhu, Takeda Pharmaceuticals ; Yi Liu, Takeda
11:35 AM	Measuring Severity of a Relapsing Disease: Non-Parametric Estimator Combining Recurrence of Events and Event-Duration — Sudipta Bhattacharya, AstraZeneca
11:50 AM	An Optimal Covariate-Adaptive Design to Balance Tiers of Covariates — Fan Wang ; Feifang Hu, George Washington University
12:05 PM	Validation of Early Functional Change Based Prognostic Groups in Predicting Long Term Depression Outcomes: Findings from COMED Trial — Abu Minhajuddin, University of Texas Southwestern-Medical Center At Dallas ; Manish K Jha, University of Texas Southwestern Medical Center ; Madhukar Trivedi, University of Texas Southwestern Medical Center

533	Wed, 8/2/2017, 12:30 PM - 1:50 PM	CC-Ballroom II
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Qi Jiang, Amgen Inc.
WL08:	Aggregate Safety Monitoring for the FDA IND Safety Reporting Final Rule — Greg Ball, Merck
WL09:	Statistical Considerations for Rare Disease Clinical Development — Yang Song, Vertex Pharmaceuticals
WL10:	Statistical Inference in the Era of Precision Medicine- the Essential Role of Statistics for Unmet Needs in Algorithm Refinement, Diagnostics Application and Drug Development — Ruixiao Lu, Genomic Health
WL11:	Beyond the Statistical Analysis Plan: Statisticians Partaking Earlier in Design of Clinical Trials — Yuqun Abigail Luo, FDA
WL12:	Unblinded Sample Size Re-Estimation for Complex Trials — Chris Holland, Amgen

551 * !	Wed, 8/2/2017, 2:00 PM - 3:50 PM	CC-313
New Innovations in Handling Incomplete Biomedical Data in the Era of Data Science — Invited Papers
International Indian Statistical Association , Biopharmaceutical Section , Biometrics Section
Organizer(s): Arkendu Sekhar Chatterjee, Associate Principal Scientist
Chair(s): Arkendu Sekhar Chatterjee, Associate Principal Scientist
2:05 PM	Interplay Between Estimands and Missing Data in Clinical Trials — David Ohlssen, Novartis
2:25 PM	Sequential BART for Imputation of Missing Covariates in the Presence of Auxiliary Covariates — Dandan Xu, The University of Texas at Austin ; Michael J Daniels, University of Texas at Austin
2:45 PM	Nonparametric Methods for Irregularly Sampled Censored Data with Applications to Liver Transplant Allocations — Sujit K Ghosh, North Carolina State University ; Bradley Turnbull, Apple Inc
3:05 PM	Bayesian Methods for Non-Ignorable Dropout in Joint Models in Smoking Cessation Studies — Jeremy Gaskins, University of Louisville ; Michael J Daniels, University of Texas at Austin
3:25 PM	Handling Incomplete Correlated Continuous and Binary Outcomes in Meta-Analysis of Individual Participant Data — Manuel Gomes, London School of Hygiene and Tropical Medicine ; Laura Anne Hatfield, Harvard Medical School ; Sharon-Lise Normand, Harvard Medical School
3:45 PM	Floor Discussion

559 * !	Wed, 8/2/2017, 2:00 PM - 3:50 PM	CC-340
CDISC Standards Usage and the Role of Biostatisticians and Programmers — Invited Papers
Section for Statistical Programmers and Analysts , Biopharmaceutical Section
Organizer(s): William Coar, Axio Research
Chair(s): Kuolung Hu, Amgen
2:05 PM	Drug Development Planning and CDISC Standards from the Perspective of a Programmer/Analyst — Michael Carniello, Astellas Pharma
2:25 PM	Evaluation of the Programmers/Statisticians Role with CDISC - a CRO Perspective — William Coar, Axio Research
2:45 PM	CDISC Submissions and the Role of Statisticians — Chris Holland, Amgen
3:05 PM	CDISC Usage in Legacy Studies — Greg Valin, Amgen
3:25 PM	Discussant: Paul Schuette, FDA CDER
3:45 PM	Floor Discussion

566 * !	Wed, 8/2/2017, 2:00 PM - 3:50 PM	CC-339
Recent Advances in Quality Statistics and Process Validation of Pharmaceuticals — Topic Contributed Papers
Section on Risk Analysis , Biopharmaceutical Section , Quality and Productivity Section , ENAR
Organizer(s): Stan Altan, Janssen R&D, LLC
Chair(s): Jyh-Ming Shoung, Janssen R&D, LLC
2:05 PM	Continued Process Verification - a Systems Approach Including Tips and Traps — Ronald D Snee, Snee Associates, LLC
2:25 PM	Recent Advances in Quality Statistics and Process Validation of Pharmaceuticals — Lynne Hare, Statistical Strategies, LLC
2:45 PM	Process Validation: Statistical Methods for Evaluating Uniformity of Dosage Units — James Bergum ; Thomas Stepinac, Novartis
3:05 PM	Improved Acceptance Limits for ASTM Standard E2810 — Richard Lewis, GlaxoSmithKline ; Ailin Fan, North Carolina State University
3:25 PM	Discussant: Stan Altan, Janssen R&D, LLC
3:45 PM	Floor Discussion

568 * !	Wed, 8/2/2017, 2:00 PM - 3:50 PM	CC-311
Simulation Report for Designing Adaptive Clinical Trials: Current Practices and Recommendations to Industry — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): cristiana mayer, Janssen R&D
Chair(s): Sergei Leonov, ICON Clinical Research
2:05 PM	Current Practices in Reporting Trial Simulations for Adaptive Study Designs — cristiana mayer, Janssen R&D ; Parvin Fardipour, ICON
2:25 PM	Practical Considerations on Simulations for Adaptive Dose Escalation and Dose Ranging Trials — Inna Perevozskaya, Glaxo SmithKline ; Alun Bedding, Roche UK ; Vladimir Dragalin, Janssen R&D ; Parvin Fardipour, ICON
2:45 PM	Simulation Considerations for Multistage Adaptive Designs and Designs with Sample Size Re-Estimation: Type 1 Error Control and Beyond — Greg Cicconetti, Abbvie ; Sergei Leonov, ICON Clinical Research ; Yili L Pritchett, MedImmune ; Michael Smith, Astellas ; Alan Hartford, AbbVie
3:05 PM	Evaluation of Simulation Models Through Different Computational Environments — Jiang Hu, FDA
3:25 PM	Discussant: Boguang Zhen, FDA CBER
3:45 PM	Floor Discussion

570 *	Wed, 8/2/2017, 2:00 PM - 3:50 PM	CC-319
More Emerging Topics in Benefit-Risk Assessment in Clinical Development Decision Making — Topic Contributed Papers
Biopharmaceutical Section , Section on Risk Analysis
Organizer(s): Weili He, Merck & Co., Inc.
Chair(s): Xiaofei Hu, Merck & Co., Inc.
2:05 PM	On a Stepwise Quantitative Approach for Benefit-Risk Assessment — Weili He, Merck & Co., Inc. ; Yaxuan Sun, Department of Statistics, Iowa State University, Ames, IA, USA ; Qing Li, Merck & Co., Inc. ; Sabrina Wan, Merck & Co., Inc.
2:25 PM	DMCS and Benefit:Risk Assessment — Scott Evans, Harvard University ; Christy Chuang-Stein, Retired! ; Dave DeMets, Retired ; Paul Gallo, Novartis ; Weili He, Merck & Co., Inc. ; Qi Jiang, Amgen Inc. ; Frank Rockhold, Retired
2:45 PM	Using Patient Preference Information in Benefit-Risk Assessment — Xuefeng Li, FDA ; George Quartey , Genetech
3:05 PM	Rationale for the Use of Subject Level Information for Benefit-Risk Evaluations — Shihua Wen, Novartis ; Weili He, Merck & Co., Inc. ; Scott Evans, Harvard University ; Qi Jiang, Amgen Inc. ; Jonathan Norton, Takeda ; Xuefeng Li, FDA ; George Quartey , Genetech
3:25 PM	Discussant: Qi Jiang, Amgen Inc.
3:45 PM	Floor Discussion

579 * !	Wed, 8/2/2017, 2:00 PM - 3:50 PM	CC-320
Tests of Noninferiority in the Clinical Trial Setting — Contributed Papers
Biopharmaceutical Section
Chair(s): Adam Hamm, Cytel, Inc.
2:05 PM	Bayesian Approach of Assessing Non-Inferiority of a New Treatment with Binary Outcomes in a Three-Arm Trial — Shrabanti Chowdhury ; Samiran Ghosh, Wayne State University - Detroit, MI ; Ram Tiwari, FDA/CDER/OT/OB
2:20 PM	A Simple Mantel-Haenszel Type Test for Non-Inferiority — Kallappa Koti
2:35 PM	Ratio of Means vs. Difference of Means Non-Inferiority or Equivalence Tests -Difference in Adjustment for Covariates — Wanjie Sun, FDA ; Stella Grosser, FDA
2:50 PM	Non-Inferiority Trial Design by Considering Maximally/Minimally Observed Treatment Difference — Shufang Liu, Astellas Pharma ; Misun Lee, Astellas Pharma
3:05 PM	Use of Historical Control Data in the Analysis of a Non-Inferiority Trial — Isaac Nuamah, Janssen R & D ; Youping Huang, Janssen R&D ; Yevgen Tymofyeyev, Janssen R&D
3:20 PM	Statistical Methods for Equivalence Assessment of Analytical Biosimilar — Yi Tsong, CDER, FDA ; Meiyu Shen, C DER, FDA ; Yu-Ting Weng, FDA ; Chao Wang, CDER/FDA ; Li Xing, CDER/FDA
3:35 PM	Immunogenicity Study Design for Biosimilar Approval — Junshan Qiu, FDA ; Mike Mikailov, FDA ; Ram Tiwari, FDA/CDER/OT/OB

606 * !	Thu, 8/3/2017, 8:30 AM - 10:20 AM	CC-337
Meta-Analysis Has Moved Beyond Its Original Niche as a Method to Provide a Summary of the Average Effect of an Intervention on an Outcome — Topic Contributed Papers
Section on Statistics in Epidemiology , Health Policy Statistics Section , Biometrics Section , Biopharmaceutical Section
Organizer(s): Christopher Schmid, Brown University
Chair(s): Thomas Trikalinos, Brown University
8:35 AM	Robust Network Meta-Analysis: a Confidence Distribution Approach — Dungang Liu, University of Cincinnati ; Guang Yang, Jet.com ; Minge Xie, Rutgers University
8:55 AM	A Robust Pseudolikelihood-Based Inference of Personalized Utility Functions Through Multiple Outcomes Network Meta-Analysis — Yong Chen, University of Pennsylvania ; Rui Duan, University of Pennsylvania
9:15 AM	Breaking the Myth of Breaking Randomization: a Causal Examination of Arm-Based Meta-Analysis — Russell Steele, McGill University ; Mireille Schnitzer, Université de Montréal ; Ian Shrier, Lady Davis Institute and McGill University
9:35 AM	Hierarchical Models for Combining N-Of-1 Trials — Youdan Wang
9:55 AM	Discussant: Christopher Schmid, Brown University
10:15 AM	Floor Discussion

607 * !	Thu, 8/3/2017, 8:30 AM - 10:20 AM	CC-341
Recent Advances in Missing Data Methods: From Estimands to Assumptions for Primary and Sensitivity Analyses — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Frank Liu, Merck & Co. Inc.
Chair(s): Devan Mehrotra, Merck & Co. Inc.
8:35 AM	Overview of Estimands, Estimators, and Sensitivity for Longitudinal Clinical Trials — Craig Mallinckrodt, Eli Lilly & Co.
8:55 AM	Comparison of Frameworks for Tipping Point Analyzes — Achim Guettner, Novartis ; Summer Xia, Novartis
9:15 AM	Multiple Imputation Using Control Quantile Statistics — David Li, Pfizer
9:35 AM	Likelihood Based Approaches for Missing Data with Imputation Guided by the Worst Observed Responses — Frank Liu, Merck & Co. Inc. ; Fang Liu, Merck & Co., Inc. ; Devan Mehrotra, Merck & Co. Inc.
11:55 AM	Discussant: Fanhui Kong, Food and Drug Administration
10:15 AM	Floor Discussion

620 * !	Thu, 8/3/2017, 8:30 AM - 10:20 AM	CC-343
Dose-Finding for Monotherapy and Combination Therapy in Oncology and Other Complex Studies — Contributed Papers
Biopharmaceutical Section
Chair(s): Godwin Yung, Takeda Pharmaceutical
8:35 AM	Dose Selection in Phase 2 Studies for a Drug Combination Using a Response Surface Modeling Technique — Hongtao Zhang, AbbVie Inc. ; Jingjing Gao, AbbVie Inc. ; Qiming Liao, AbbVie Inc. ; Alan Hartford, AbbVie ; Jyotirmoy Dey, AbbVie Inc.
8:50 AM	Incorporating Pharmacokinetic Assessment in Bayesian Phase I Trial Design in Oncology Area — Kentaro Takeda, Astellas Pharma Global Development, Inc. ; Kanji Komatsu, Astellas Pharma Inc. ; Satoshi Morita, Kyoto University Graduate School of Medicine
9:05 AM	Impact of Mis-Specified Prior in Combination Dose Finding — Lixia Pei, Janssen Research & Development
9:20 AM	Design of Phase I/II Drug Combination Cancer Trials Using CRM and Adaptive Randomization — Mourad Tighiouart, Cedars-Sinai Medical Center ; Matthieu Clertant, Cedars-Sinai Medical Center
9:35 AM	A Personalized Bayesian Information-Driven Dose-Finding Design — Ilaria Domenicano, Dana-Farber Cancer Institute/University of Rome
9:50 AM	Multiplicity Adjustment in Two Dose-Response Study Examples — Li He, Merck Research Laboratories ; Joseph Heyse, Merck & Co., Inc.
10:05 AM	Continual Reassessment Method for Partially Ordered Groups — Bethany Horton, The University of Virginia ; Nolan Wages, The University of Virginia ; Mark Conaway, The University of Virginia

646 *	Thu, 8/3/2017, 10:30 AM - 12:20 PM	CC-317
Big Data with Bite-Sized Solutions — Topic Contributed Papers
Section for Statistical Programmers and Analysts , Biopharmaceutical Section , Section on Statistical Learning and Data Science , Conference on Statistical Practice Steering Committee
Organizer(s): Vipin Arora, Eli Lilly and Company
Chair(s): Ram Tiwari, FDA/CDER/OT/OB
10:35 AM	Big Data with Bite Size Solutions — Spencer Lourens, Indiana University
10:55 AM	Piecewise Solutions to Big Data — Anuradha Roy, The University of Texas at San Antonio ; Henry Chacon, The University of Texas at San Antonio
11:15 AM	Leveraging Machine Learning in the Analysis of Safety Data in Drug Research and Healthcare Informatics — Melvin Munsaka, Safety Statistics and Observational Res Analytics, Takeda
11:35 AM	Uncovering What Is Inside the Data Using Effective Visualization — Vipin Arora, Eli Lilly and Company ; Xiang Zhang, Eli Lilly and Company
11:55 AM	Discussant: Judith D. Goldberg, New York Unversity School of Medicine
12:15 PM	Floor Discussion

650 *	Thu, 8/3/2017, 10:30 AM - 12:20 PM	CC-341
On the Use of Computer-Intensive Methods in Pharmaceutical Research — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Robert D. Small, Sanofi Pasteur
Chair(s): John Jezorwski, Janssen, Research & Development, Pharmaceutical Companies of Johnson & Johnson
10:35 AM	Predicting Subject Enrollment in Clinical Trials — Matthew Austin, Amgen, Inc.
10:55 AM	Two Trends in Solutions to Computation-Intensive Methods: Laptop vs. Graphics Processing Unit (GPU) — Junshui Ma, Merck & Co., Inc. ; Vladimir Svetnik, Merck & Co., Inc.
11:15 AM	Efficient Affine Invariant Clustering with Gaussian Models of General Covariance Structures — Hsin-Hsiung Huang, UCF
11:35 AM	On the Use of Empirical Bayes Techniques to Bridge from an in Vitro System to a Clinical Trial — Ya Meng, Sanofi Pasteur ; Camille Salamand, Sanofi Pasteur ; Robert D. Small, Sanofi Pasteur
11:55 AM	Discussant: Lihan Yan, Vaccine Evaluation Branch-CBER-FDA
12:15 PM	Floor Discussion

651 * !	Thu, 8/3/2017, 10:30 AM - 12:20 PM	CC-310
Perception and Use of Adaptive Designs in Industry and Academia: Comparison of the Four DIA Adaptive Design Scientific Working Group Surveys Conducted from 2000 Through 2015 — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Eva R Miller, INC Research
Chair(s): Eva R Miller, INC Research
10:35 AM	Motivation and Design of the DIA Adaptive Design Scientific Working Group (DIA ADSWG) Survey for the Perception and Use of Adaptive Designs in Pharmaceutical Clinical Development — Alan Hartford, AbbVie
10:55 AM	Perception and Use of Adaptive Designs in the Industry and Academia: Comparison of the DIA Adaptive Design Scientific Working Group Surveys with Emphasis on Improvements Over Time — Mitchell Thomann
11:15 AM	Literature Review Providing a Summary of Adaptive Design Usage in Pharmaceutical Clinical Development — Xiaotian Chen
11:35 AM	Perception and Use of Adaptive Designs in Industry and Academia - Findings of a Review of Registries — Lingyun Liu, Cytel, Inc
11:55 AM	Comparison of the DIA Adaptive Design Scientific Working Group Surveys Conducted from 2000 Through 2015, with an emphasis on perceived and persistent barriers to adoption — Alun Bedding, Roche UK
12:15 PM	Floor Discussion

659 * !	Thu, 8/3/2017, 10:30 AM - 12:20 PM	CC-342
Clinical Trial Research — Contributed Papers
Biopharmaceutical Section
Chair(s): Brian Wiens, Tobira Therapeutics
10:50 AM	A Robust Paradigm of Finding the Maximum Tolerated Dose in Phase I Cancer Clinical Trials — Tina Young, Bristol-Myers Squibb ; Dirk Moore, Rutgers School of Public Health ; Yong Lin, Rutgers ; Weichung Joe Shih, Rutgers School of Public Health
11:05 AM	Impact of Assessment of Schedule Interval Change on Median Progression-Free Survival Estimate — Shuyan Wan, Merck
11:20 AM	A Two-Stage, Phase II Clinical Trial Design with Nested Criteria for Early Stopping and Efficacy — Michelle DeVeaux, Yale University ; Daniel Zelterman, Yale University ; Michael Kane, Yale University
11:35 AM	Program Success Criteria for Drug Approval: P Value vs. Bayesian Posterior Probability — Meihua Wang, Merck & Co. ; Frank Liu, Merck & Co. Inc.
11:50 AM	Constructing a Synthetic Control Arm from Previous Clinical Trials, with Application to Cancer Trials — Steven Schwager, Medidata Solutions ; Michael Elashoff, Medidata Solutions ; Philip Beineke, Medidata Solutions ; Ruthanna Davi, Medidata Solutions
12:05 PM	Select a Better Treatment Using Efficacy Safety and Patients' Preference — Kao-Tai Tsai

660 * !	Thu, 8/3/2017, 10:30 AM - 12:20 PM	CC-343
Biomarkers in Clinical Research and Development — Contributed Papers
Biopharmaceutical Section , Section on Statistics in Genomics and Genetics
Chair(s): Jonathan Moscovici, QuintilesIMS
10:35 AM	Modeling and Simulation to Detect Unusual Patterns in Genotoxicity Data (Microbial Assays) — Elena Rantou, FDA/CDER
10:50 AM	A Hypothesis Testing Framework for Validating an Assay for Precision — Michael Fay, National Institute of Allergy and Infectious Diseases ; Michael C Sachs, Karolinska Institutet ; Kazutoyo Miura, National Institute of Allergy and Infectious Disease
11:05 AM	Theoretical and Practical Considerations in Estimation of Heritability on Drug Response from Whole Genome and Molecular Signature SNPs — Wencan Zhang, Takeda Development Center ; Lin Li, BioStat Solutions, Inc. ; Pingye Zhang, Merck ; Yonghong Zhu, Takeda Development Center ; Ling Wang, Takeda Development Center ; Ray Liu, Takeda Development Center
11:35 AM	Floor Discussion

JSM 2017 Online Program

Activity Details

ASA Meetings Department

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